10,f]azepine monohydrochloride

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ACTIVE PHARMA INGREDIENTS

6 API Suppliers, 6 USDMF, 2 NDC API, 1 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

69 FDF Dossiers, 59 FDA Orange Book, 10 Canada

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG, TABLET;ORAL - 10MG, TABLET;ORAL - 150MG, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG, TABLET;ORAL - 75MG

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 4 DKSH, 2 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 2 Aeon Procare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 10 Corel Pharma Chem, 7 DFE Pharma, 1 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 22 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

91 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 47 Direct Compression, 30 Disintegrants & Superdisintegrants, 29 Controlled & Modified Release, 28 Granulation, 25 Thickeners and Stabilizers, 23 Solubilizers, 21 Co-Processed Excipients, 20 Lubricants & Glidants, 19 Taste Masking, 17 Chewable & Orodispersible Aids, 15 Parenteral, 12 Topical, 12 Film Formers & Plasticizers, 8 Emulsifying Agents, 8 API Stability Enhancers, 5 Empty Capsules, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents

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REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 1 Others

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USFDA APPLICATION NUMBER - 14399 / DOSAGE - TABLET;ORAL - 150MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
desipramine hydrochloride(UNII: 1Y58DO4MY1) (desipramine - UNII:TG537D343B)	desipramine hydrochloride	150mg \| 100mg \| 75mg \| 50mg \| 25mg \| 10mg

Inactive Ingredients

Ingredient Name	sanofi-aventis U.S. LLC	Winthrop U.S.	Bryant Ranch Prepack	CorePharma, LLC	Actavis Pharma, Inc.	ANI Pharmaceuticals, Inc.	KAISER FOUNDATION HOSPITALS	Preferred Pharmaceuticals, Inc.	Sandoz Inc	Preferred Pharmaceuticals Inc.
acacia(5C5403N26O)
calcium carbonate(H0G9379FGK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C Red No. 30(2S42T2808B)
D&C Yellow No. 10(35SW5USQ3G)
FD&C Blue No. 1(H3R47K3TBD)
ferric oxide red(1K09F3G675)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
light mineral oil(N6K5787QVP)
MAGNESIUM STEARATE(70097M6I30)
mannitol(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 400(B697894SGQ)
polyethylene glycol 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium benzoate(OJ245FE5EU)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
sucrose(C151H8M554)
talc(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: 10,f]azepine monohydrochloride