Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072079
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/20/1988 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2019 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/06/2015 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

04/23/2014 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

02/14/2001 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/22/1995 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/29/1993 SUPPL-7 Labeling

Label is not available on this site.

01/27/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/25/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/25/1993 SUPPL-4 Labeling

Label is not available on this site.

03/10/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/24/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DIAZEPAM

INJECTABLE;INJECTION; 10MG/2ML (5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Prescription No AP 210363 BELOTECA INC
DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Prescription No AP 072079 HOSPIRA

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