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DIAZEPAM

ANDA

DIAZEPAM | A072079 | HOSPIRA INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from RegCon Solutions LLC FDA-2015-P-3407 · 5 docket documents RegCon Solutions LLC submitted this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Hospira's Diazepam Injection 10 mg/2mL (ANDA 072079) as a reference-listed drug in the Orange Book so that generic versions of this product could be	Other	2015-11-03	Granted	RegCon Solutions LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$237.19

Highest Price

$237.19

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00409-1273-32DIAZEPAM 5MG/ML INJ	$237.19	FSS	Pfizer Inc.	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain5 active DMFs4 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

CAMBREX PROFARMACO MILANO SRLDIAZEPAM

DMF 14781970

FIS FABBRICA ITALIANA SINTETICI SPADIAZEPAM

DMF 31641978

CENTAUR PHARMACEUTICALS PRIVATE LTDDIAZEPAM USP

DMF 218602008

R L FINE CHEM PVT LTDDIAZEPAM

DMF 338582019

NAVINTA LLCDIAZEPAM USP

DMF 388442023

DELMAR CHEMICALS INCInactiveDIAZEPAM USP BULK

DMF 25821976

POLFA TARCHOMINInactiveDIAZEPAM, BULK

DMF 35231979

GEDEON RICHTER LTDInactiveDIAZEPAM USP

DMF 60711985

FDC PRIVATE LTDInactiveDIAZEPAM U.S.P. XXI

DMF 70251987

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 10MG/2ML (5MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 20, 1988

No patent or exclusivity listings for this strength.