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Details for New Drug Application (NDA): 070920

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NDA 070920 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 forty 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. Forty-one suppliers are listed for this compound. Additional details are available on the temazepam profile page.

Summary for NDA: 070920

Tradename:
TEMAZEPAM
Applicant:
Mylan
Ingredient:
temazepam
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 070920

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 070920

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMAZEPAM
temazepam
CAPSULE;ORAL 070920 ANDA Mylan Pharmaceuticals Inc. 0378-3110 0378-3110-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
TEMAZEPAM
temazepam
CAPSULE;ORAL 070920 ANDA Mylan Pharmaceuticals Inc. 0378-3120 0378-3120-93 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Jul 10, 1986TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength7.5MG
Approval Date:May 21, 2010TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength22.5MG
Approval Date:Jun 12, 2009TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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