Clorazepate Dipotassium

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ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 8 USDMF, 2 CEP/COS, 1 JDMF, 4 NDC API, 5 Listed Suppliers, $ API Reference Price

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

112 FDF Dossiers, 85 FDA Orange Book, 23 Europe, 3 Canada, 1 South Africa

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 1 DKSH, 3 Gangwal Healthcare, 2 Kirsch Pharma, 2 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 5 BASF, 1 CD Formulation, 3 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 1 Ideal Cures, 1 Ingredion Pharma Solutions, 1 Kerry, 2 Keval Exports, 8 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 8 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

21 Fillers, Diluents & Binders, 15 Lubricants & Glidants, 13 Disintegrants & Superdisintegrants, 10 Granulation, 10 Direct Compression, 9 Thickeners and Stabilizers, 7 Co-Processed Excipients, 6 Controlled & Modified Release, 5 Coating Systems & Additives, 5 Parenteral, 4 Emulsifying Agents, 4 Taste Masking, 3 Chewable & Orodispersible Aids, 2 Rheology Modifiers, 2 Film Formers & Plasticizers, 2 API Stability Enhancers, 1 Surfactant & Foaming Agents, 1 Topical

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GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 6 Regulatory FDF Prices

MARKET PLACE

2 APIs

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REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 17105 / DOSAGE - CAPSULE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLORAZEPATE DIPOTASSIUM(UNII: 63FN7G03XY) (CLORAZEPIC ACID - UNII:D51WO0G0L4)	CLORAZEPATE DIPOTASSIUM	7.5mg \| 7.5mg

Inactive Ingredients

Ingredient Name	AbbVie Inc.	RECORDATI RARE DISEASES, INC.
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FD&C YELLOW NO. 6(H77VEI93A8)
MAGNESIUM OXIDE(3A3U0GI71G)
MAGNESIUM STEARATE(70097M6I30)
POTASSIUM CARBONATE(BQN1B9B9HA)
POTASSIUM CHLORIDE(660YQ98I10)
SILICON DIOXIDE(ETJ7Z6XBU4)
TALC(7SEV7J4R1U)

Setid 9c7ab45c 7461 6e4e Ee6d F0ebe3eb4a28 Applno 17105 Form Capsule Oral Dosage 15mg - Drug Product Composition: Clorazepate Dipotassium