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Details for New Drug Application (NDA): 071638

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NDA 071638 describes TEMAZEPAM, which is a drug marketed by Duramed Pharms Barr, Actavis Elizabeth, Mylan, Sandoz, Watson Labs, Novel Labs Inc, Sun Pharm Inds, Vintage Pharms, Amneal Pharms, and Usl Pharma, and is included in twenty NDAs. It is available from thirty-eight suppliers. Additional details are available on the TEMAZEPAM profile page.

The generic ingredient in TEMAZEPAM is temazepam. There are seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the temazepam profile page.

Summary for NDA: 071638

Actavis Elizabeth

Pharmacology for NDA: 071638


Suppliers and Packaging for NDA: 071638

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 071638 ANDA KAISER FOUNDATION HOSPITALS 0179-1470 0179-1470-01 100 CAPSULE in 1 BOTTLE (0179-1470-01)
CAPSULE;ORAL 071638 ANDA KAISER FOUNDATION HOSPITALS 0179-1470 0179-1470-30 30 CAPSULE in 1 BOTTLE (0179-1470-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Aug 7, 1987TE:ABRLD:No

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