Clorazepate Dipotassium

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ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 7 USDMF, 2 CEP/COS, 1 JDMF, 3 NDC API, 5 Listed Suppliers, $ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

114 FDF Dossiers, 85 FDA Orange Book, 25 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TABLET;ORAL - 11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 1 Jai Radhe Sales, 5 Faran Shimi Pharmaceutical, 7 Gangwal Healthcare, 2 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 5 BASF, 3 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 3 Kerry, 8 Microlex e.U, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 8 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Vasa Pharmachem

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GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 28 Finished Drug Prices

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REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 1 Others

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USFDA APPLICATION NUMBER - 17105 / DOSAGE - TABLET;ORAL - 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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)

Drug Product Composition: Clorazepate Dipotassium