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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, Hikma Maple , Warner Chilcott, Watson Labs, Eurohlth Intl Sarl, 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-one NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: diazepam

Tradenames:8
Patents:0
Applicants:30
NDAs:81
Drug Master File Entries: see list8
Suppliers / Packaging: see list45
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
Hikma Maple
DIAZEPAM
diazepam
INJECTABLE;INJECTION071310-001Jul 17, 1987DISCNNo<disabled><disabled>
Watson Labs
DIAZEPAM
diazepam
INJECTABLE;INJECTION070296-001Feb 12, 1986DISCNNo<disabled><disabled>
Pioneer Pharms
DIAZEPAM
diazepam
TABLET;ORAL070788-001Aug 2, 1988DISCNNo<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
Valeant Pharms North
DIASTAT ACUDIAL
diazepam
GEL;RECTAL020648-006Sep 15, 20055,462,740<disabled>
Roche
VALRELEASE
diazepam
CAPSULE, EXTENDED RELEASE;ORAL018179-001Approved Prior to Jan 1, 19824,316,897<disabled>
Roche
VALIUM
diazepam
TABLET;ORAL013263-006Approved Prior to Jan 1, 19824,316,897<disabled>
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