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HomeDrugsDrug Master Files (DMF)DMF Examples ›DMF Type IV Examples

DMF Type IV Examples

The following are examples of DMFs filed with the U.S. Food and drug Administration (U.S. FDA).

NOTE:The following is for informational purposes only. This is not a complete or comprehensive list. If you have questions about specific Type IV DMFs, please   contact us.

1101P3CP1 Red 1608 1200 Grade and 1250 Grade Alcohol 25% Ammoniated Shellac Solution
40ml White Bell Round Hdpe Cylinder 4910 Unfilled Elastomer 70000 and 70001 Silicone Elastomers
A,A-Trehalose Dihydrate AC-DI-SOL Modified Cellulose Gum Acesulfame Potassium
Acrylic Adhesive Emulsions Acrypol Carbomer Additives
Advantia Performance Advantia(Tm) Prime Aerolac
Aerosil Akucell AF2781 Alcogum 1370
All In Gum SF Art Alpha-Cyclodextrin Alva Flavors, Sealva Flavors
Anise Type Flavor, Natural Aquacoat Tm ECD-30 Aqualic AS58 an Excipient
Aquarius(Tm) Coatings Systems Aqueous Glaze Sb-1*P Arancia Flavor E 9940619*01
Arkon P-100 (Excipient) Art Grape Base Art Grape Flvp
Art. Strawberry Flavor Artificial Bitter Masking Flavor Artificial Bubble Gum Flavor
Artificial Bubblegum Flvp Artificial Burnt Sugar Flavor Artificial Cherry Flavor
Artificial Cooling Compound Artificial Cotton Candy Flavor Artificial Cream Flavor
Artificial Grape Flavor Artificial Masking Agent Fl Artificial Menthol Flavor
Artificial Mixed Berry Flavor Artificial Pineapple Flavor Artificial Raspberry Flavor
Artificial Strawberry Base Oil Artificial Strawberry Flavor Artificial Strawberry Flvp
Artificial Sweet Cherry Flavor Artificial Sweetness Enhancer Artificial Vanilla Cream Flavor
Artificial Vanilla Flavor Azone(R), an Inactive Ingredient Banana Flavor E_0501695
Banana Flavor E_9930469 Beta Cyclodextrin Beta-Cyclodextrin
Biodegradable Polymer Excipients Biodegradable Polymers Biosustane(R) SAIB
Blackcurrant Flavour Bupivacaine Hydrochloride Cafosa 257 Classic
Cafosa 258 Soft Cal-Carb Calcium Alginate
Calcium Silicate Calciumbutrol C-A-P(Tm) Cellulose Ester
Capryol(R) 90 and Capryol(R) PGMC Capsules Captisol R Excipient
Carbopol 1984, 2984 and 5984 Resins Carbopol 974p and 971P Carbopol 980 NF
Carbopol 981 NF Carboxymethylcellulose Sodium USP Carmellose JP
Cellulose Acetate Butyrate NF Cellulose Acetateanalyzed Certiseal A-100
Certiseal FC-300 Certiseal FC-300A Cetiol SN Ph
Cetiol V Ph Cetiol(R) LC Ph Cherry Flavor, Artificial
Cherry Flavour Chewing Gum Base: Dan Med 60 M*BHT Chitopharm L
Chitopharm M Chitopharm S Chitosan (Trade Name Protasan(Tm))
Chlorofluorocarbon 11, 12, and 114 Chlorofluorocarbon Propellant P-11 Chlorofluorocarbon Propellant P-114
Chlorofluorocarbon Propellant P-12 Cinnamon Flavor Natural CLZ-42
Colorcon NO-Tox(R) Products Compritol 888 (an Excipient) Contramid 92450
Controlled Release Excipient CPL-Galactolipid Cremophor Surfactant RH40
Crillet 4 HP Crillet 4 HPTS (Polysorbate 80) Crodamol DA (Diisopropyl Adipate)
Crodesta SL 40E (Sucrose Cocoate) Croscarmellose Sodium NF Croscarmellose Sodium USP
Croscarmellose Sodium USP-NF Croscarmellose Sodium, NF Croscarmellose USP*NF
Crystalac Glaze Formula C Crystalline Maltose Cutina CP Ph
Cutina GMS V Ph Cutina HR Ph DDU-310 Silicone Fluid
DDU-4340 Silicone Elastomer DDU-4630 Silicone Elastomer Dehymuls HRE 7
Diazolidinyl Urea, (Germall II) Dierucoylphosphatidylcholine (DEPC) Dimyristoyl Phosphatidyl Choline
Distearoyl Phosphatidyl Choline Dow Corning 360 Medical Grade Fluid Dowex 1 & 2 Anion Exchange Risin
Dreyco(R) Chewing Gum Base Drycell Citron Flavour Drycell Orange Flavour
Drycell Yogurt Flavour DSPE-Peg 5000 Duro-Tak 280-2516
Dymel 227 EA*P (Heptafluoropropane) Dynapore Long Fibre Paper 026 E_0405329 Strawberry Flavor
Eastman Vitamin E TPGS 1000 Edible Inks Efferves (Amino Acid Complex)
Egg Phosphatide Egg Yolk Phospholipid (EYP) Emcosoy
Empty Gelatin Capsule Empty Gelatin Capsule (Hard Shell) Empty Gelatin Capsules
Empty Hard Gelatin Capsules Empty Hard Vegetable Capsule Shells Empty Pondac Capsules
Emulfree(R) P Pharma Emulsifier 10 Ethyl Lactate, Pharmaceutical Grade
Eucalyptus Oil 70*75% Eudragit FS 30 D Eudragit L 30 D-55
Eudragits Eumulgin B1 Ph Eumulgin B2 Ph
Eutanol(R) G Eutanol(R) G Ph Evogran Cappuccino Flavor
Excipient Cellulose Capsule Shells Excipient KE-311 Excipient Marking Solution
Extracts & Flavors F001 Granulation Flavor and Fragrance Information
Flavor Formulas Flavor Formulations Flavor Potentiator 2-100
Flavors F-Melt Type C (Excipient) Fruit Punch Flavour SD 204264
Fujicalin Galactomannan C (Davanat) Gamma Cyclodextrin
Ganex V-220 (VP*Eicosene Copolymer) Gelatin Gelatin Capsules
Gelatin Mass for Soft Gel Capsules Gelatin Type B Gellan Gum Gelrite MK
Glucopon 625 UP GM 9011*C Grape Flavour
Grape Nat*Art Flavor Grapefruit Flavor, Natural Wonf Hard Gelatin Capsule Shells
Hard Shell Gelatin Capsules Hayashibara Pullulan HD Eutanol V Ph
HDW-2002 Prepolymer HFC134A (Tetrafluoroethane) HMS Lactose DT
Honey Flavor, Artificial Honeywell Pharmaceutical HFA-134A Hydropropyl Methlcellulose
Hydroxyethyl Cellulose Hydroxypropyl Beta Cyclodextrin Hydroxy-Propyl Beta-Cyclodextrin
Hydroxypropyl Cellulose Hypromellose Phthalate Imwitor 742
Indion 204 Indion 234 Inhalation Grade Lactose (IGL)
Inhalation Lactose Instacoat Colour Irgasurf Hl560
Isomalt Isopropylmyristat Ph Isopropylpalmitat Ph
Kollicoa(R) IR Kollicoat Mate 30DP Kollicoat SR 30 D
Kollicoat(R) IR White Kollicoat(R) Protect Kollidon (R) Polyvinylpyrrolidone
Kollidon SR Kollidon VA 64 Kyron Polacrillin Potassium
Labrafil M 1944 CS Labrafil M 2125 CS Labrafil M 2130 CS
Labrasol Lactose Anhydrous NF Inhalation 40M Lake, Dye, and Pigment Blends
Lanette N Ph L-A-Phosphatidylcholine Dipalmitoyl Lauroglycol
Lemon Flavor, Nat & Art Lemon Flavour Lime Flavour
Lipoid PA 16:0*16:0 Lipoid PC 14:*14:0 Lipoid PC 16:0*16:0
Lipoid PC 16:0*18.1 Lipoid PC 18:0*18:0 Lipoid PC 18:1*18:1 (DOPC)
Lipoid PG 18:0*18:0 Lipoid S 100 Lipoid S 75
Lipoid S 75-Miglyol Lipoid S PC-3 Lipoid TG 8:0*8:0*8:0 (Tricaprylin)
Lipoxol(R) Med L-Leucine (U-13C6) Macat LB
Magnesium Stearate Magnesium Stearate USP Makrolon 2458-1112 and 1117
Mannitol USP Powder Pearlitol (R) Mantrocel E-4000 Mantrocel E5, E6, E15 and E50
Mantrocel HP55-HPMCP Marcoat 125 Marcoat 125N
Marine Colloids Carrageenan Masking Agent Flavor, Artificial MDX-4-4159 Fluid
MDX-4-4210 Clean Grade Elastomer Medisorb Meggle Cellactose 80
Menthol Flavor, Natural Menthol USP Methocel
Methyl Beta-Cyclodextrin Microcelac 100 Microcrystalline Cellulose
Microcrystalline Cellulose USP Microcrystalline Cellulose USP NF Microcrystalline Cellulose USP-NF
Miglyol 829 Milk Flavour Mint Flavor E_0325609
Mixed Berries Flavour Monomuls 90-L 12 Montanide ISA 51
Montanide ISA 51 Sterile Montanide ISA" 720 VG Sterile Montanov 68 Pha
MPEG5000 M-Pyrol (N-Methylpyrrolidone) Multipor Coating Polymer
Myritol(R) 318 Ph N&A Cherry Type Flavor N&A Cinnamon Flavor
N&A Menthol Flvp N&A Orange Flavor N&A Peppermint Flvp
N*A Citrus Flavor N*A Banana Flavor WS N*A Berry Flavor
N*A Blueberry Flavor N*A Cherry Berry Fl N*A Cherry Flvp Flavor WS
N*A Cough Syrup Masker Flavor N*A Fruit Flavor N*A Grape Flavor
N*A Masker Flavor N*A Pineapple Flavor N*A Strawberry Fl WS
N*A Strawberry Flavor N*A Tropical Punch Fl Nat & Art Spearmint Flavor
Nat Cinnamon Flavor (Wonf) Nat Pineapple Flavor (Wonf) Nat. Mixed Berry Flavor Wonf
Natural & Artificial Cherry Flvp Natural & Artificial Citrus Flavor Natural & Artificial Grape Flavor
Natural & Artificial Menthol Flavor Natural & Artificial Orange Flavor Natural and Artificial Mint Flavor
Natural Banana Flavor Wonf Natural Coffee Concentrate Natural Flavor, Grape Type
Natural Grape Flavor Wonf Natural Grapefruit Extract (Wonf) Natural Lemon Flavor Wonf
Natural Lemon Lime Flavor Wonf Natural Mint Flavor Natural Orange Flavor Wonf
Natural Peppermint Ext. Natural Peppermint Flavor Natural Peppermint Flavor Extract
N-C Art Pineapple Flavor N-C Artificial Banana Flavor N-C Artificial Strawberry Flavor
N-C Artificial Wild Cherry Flavor N-C Cherry Berry Flavor Artificial N-C Cherry Flavor Artificial
N-C Cooling Flavor, Natural N-C Eucalyptus Flavor Natural N-C Nat & Art Orange Flavor
N-C Nat & Art Spearment Flavor N-C Nat Banana Flavor (Wonf) N-C Natural Mint Flavor (Wonf)
N-C Peppermint Flavor, Natural N-C Tripleberry Flavor Artificial Neowater
Nonpareil-103 Nonpareil-108 Nonpareils (Sugar Spheres NF)
Nonpariel-105T Norflurane Oleylamine, Purified (an Excipient)
Onamer(R) M, Polyquaternium-1 Optacool(R) C Special Flavoring Optamint Rose Flavor
Orange Flavor S.D. E_9816597 Orange Flavour Ora-Sweet Ora-Sweet SF and Ora-Plus
Oxacyclohexadecan-2-One Panalane(R) Polybutene Products Pancogene(R) Marin
Passion Fruit Flavour Patent Blue Violet PDMS 372 Tubing
PDMS 373 TW PDMS 373MI Tubing Peach Flavor, Natural (Wonf)
Peceol Isotearique Peppermint Flavour Pharmaburst(Tm) B Series Products
Pharmaburst(Tm) C1 Pharmaceutical Starches Pharmagum(Tm) C
Pharmatose 200 M (DPI Quality) Pharmatose(R) DCL 11 Pharmatose(R) DCL 21
Phosol 50 PG Phosphatidychloline Drug Excipient Phospholipid DMPC
Phospholipid-DSPC Phospholipon 100H Gmbh Pib Adhesive
Plantacare 2000 UP Plas II Plastoid B
Poly(2-Hydroxymethyl Methacrylate) Polyalditol Polylactic Acid (PLA)
Polysaccharide Empty Hard Capsules Polyvinyl Acetate Phthalate Povidone K30
Precipitated Silica Precirol A05 Pregelatinized Starch Pcs
Pressure Sensitive Adhesives Primellose (Croscarmellose Sodium) Primogel (Na Starch Glycolate)
Propylene Glycol Monocaprylate Protanal(R) Sodium Alginate, NF Purity 21 (45-0821)
Quintac 3570C (an Excipient) Refined Egg Phosphatide Respitose Ml001
Respitose Ml002 Respitose Ml003 Respitose SV 001 (DPI Quality)
Respitose SV 003 Roderm MD-153 Rubber Adhesive Roderm Solvent Acrylic Adhesives
Sepineo" P 600 Sheffield Coating System Clear Sheffield Coating System Clear Ent
Sheffield Coating System Clear K Sheffield Coating System Clear S Sheffield Coating System Clear S2
Sheffield Coating System White Sheffield Coating System White Ent Sheffield Tabletting System DTFD
Sheffield Tabletting System DTHV Sheffield Tabletting System ODT Silastic Med Adhesive Silicone A
Silfar S 184 Silfar(R) SE 4 Sodium Alginate
Sodium Aluminum Silicate Sodium Bicarbonate Products Sodium Starch Glycolate USP*NF
Sodium Stearyl Fumarate Softigen 767 Excipients Softisan 378
Solupor (UHWM-PE) Solutab Croscarmellose Sodium Sorbitol Special (Plasticizer)
Sour Cherry Flavour Spearmint Flavor S.D. E_9822433 Spearmint Flavour
Speziol C16 Pharma Speziol C16-C18 Pharma Speziol C18 Ph
Speziol L2SM GF Pharma Speziol L2SM GS Pharma Spray Dried Artificial Grape Flavor
Spraymix Spraysphere St Elastomer 10
Starlac St-Cyclomethicone 5-NF Stear-O-Wet M
Strawberry Flavor, Natural Wonf Strawberry Flavour Sugar Sphere
Sulphobutylether Beta-Cyclodextrin Super Refined Polysorbate 80 Synthetic Aluminum Silicate
Tabcoat TC* Tabulose and Tabulose-FG TD-1B Adhesive
Tefose 63 SD Texapon K 12 G Ph Texapon K 12 P Ph
Thaumatin Timerx Controlled Release Systems Transcutol
Trehalose Triethyl Citrate FCC Tristar NF and Tristar 149
Unfilled Silicone Elastomer Gels Unitab, Microcrystalline Cellulose Vanilla Flavour
Vanillin, Artificial Vasagel (Sodium Starch Glycolate) Vasalose (Croscarmellose Sodium)
Vcaps*Vcaps Plus W.S. Artificial Cherry Flavor Walocel(R) HM Hypromellose USP
Watermelon F-11420 Waxes & Wax Formulations Wecobee Bases
Wecobee M Wincoat*Selecoat (Coating Material) Wintergreen Flavour
Witepsol, Hard Fat Suppository Base Zetesol Les 2 Zytan (Galloquinate)

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U.S. FDA Regulations:

U.S. FDA DMF Regulation: 21 C.F.R. Section 314.420

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