Zolpidem Tartrate

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ACTIVE PHARMA INGREDIENTS

62 API Suppliers, 34 USDMF, 22 CEP/COS, 12 JDMF, 11 EU WC, 9 KDMF, 11 NDC API, 26 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

263 FDF Dossiers, 82 FDA Orange Book, 121 Europe, 12 Canada, 22 South Africa, 26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 5MG, TABLET, EXTENDED RELEASE;ORAL - 12.5MG, TABLET, EXTENDED RELEASE;ORAL - 6.25MG, SPRAY, METERED;ORAL - 5MG/SPRAY, TABLET;SUBLINGUAL - 1.75MG, TABLET;SUBLINGUAL - 3.5MG

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EXCIPIENTS BY APPLICATIONS

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DIGITAL CONTENT

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GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 113 Finished Drug Prices, 13 Annual Reports

MARKET PLACE

10 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

13 US Patents, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 10 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 22328 / DOSAGE - TABLET;SUBLINGUAL - 1.75MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
zolpidem tartrate(UNII: WY6W63843K) (zolpidem - UNII:7K383OQI23)	zolpidem tartrate	3.5mg \| 1.75mg

Inactive Ingredients

Ingredient Name	Lupin Pharmaceuticals,Inc.	Novel Laboratories, Inc.	Purdue Pharma LP
ASPARTAME(Z0H242BBR1)
croscarmellose sodium(M28OL1HH48)
CROSPOVIDONE(2S7830E561)
crospovidone(68401960MK)
CROSPOVIDONE, UNSPECIFIED(2S7830E561)
ferric oxide yellow(EX438O2MRT)
MAGNESIUM STEARATE(70097M6I30)
mannitol(3OWL53L36A)
POLYVINYL ACETATE PHTHALATE(58QVG85GW3)
POVIDONE(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium bicarbonate (8MDF5V39QO)
SODIUM BICARBONATE(8MDF5V39QO)
sodium carbonate(45P3261C7T)
sodium stearyl fumarate(7CV7WJK4UI)
sorbitol(506T60A25R)
sucralose(96K6UQ3ZD4)

Drug Product Composition: Zolpidem Tartrate