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Diazepam - Generic Drug Details

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Diazepam is the generic ingredient in eight branded drugs marketed by Martec Usa Llc, Sandoz, Ferndale Labs, Actavis Elizabeth, Ivax Sub Teva Pharms, Eurohlth Intl Sarl, Warner Chilcott, Watson Labs, Roxane, Parenta Pharms, Quantum Pharmics, Us Army, Mylan, Dava Pharms Inc, Lannett Holdings Inc, Valeant Pharms North, Vintage Pharms, Barr, Teva Pharms, Halsey, Abraxis Pharm, Par Pharm, Roche, Watson Labs Inc, Marsam Pharms Llc, Pioneer Pharms, Hospira, Pharmacia And Upjohn, and Duramed Pharms Barr, and is included in eighty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for diazepam. Forty-six suppliers are listed for this compound.

Summary for Generic Name: diazepam

Tradenames:8
Patents:0
Applicants:29
NDAs:82
Drug Master File Entries: see list8
Suppliers / Packaging: see list46
Formulation / Manufacturing:see details

Pharmacology for Ingredient: diazepam

Clinical Trials for: diazepam

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche
VALIUM
diazepam
TABLET;ORAL013263-002Approved Prior to Jan 1, 1982RXNo<disabled><disabled>
Sandoz
DIAZEPAM
diazepam
TABLET;ORAL070303-001Dec 20, 1985DISCNNo<disabled><disabled>
Ivax Sub Teva Pharms
DIAZEPAM
diazepam
TABLET;ORAL070362-001Sep 4, 1985DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: diazepam

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche
VALIUM
diazepam
TABLET;ORAL013263-006Approved Prior to Jan 1, 19824,316,897<disabled>
Pharmacia And Upjohn
DIZAC
diazepam
INJECTABLE;INJECTION019287-001Jun 18, 1993RE32393<disabled>
Roche
VALIUM
diazepam
TABLET;ORAL013263-002Approved Prior to Jan 1, 19824,316,897<disabled>
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