Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074468
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CIMETIDINE HYDROCHLORIDE EQ 360MG BASE/100ML INJECTABLE;INJECTION Discontinued None No No
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CIMETIDINE HYDROCHLORIDE EQ 480MG BASE/100ML INJECTABLE;INJECTION Discontinued None No No
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CIMETIDINE HYDROCHLORIDE EQ 180MG BASE/100ML INJECTABLE;INJECTION Discontinued None No No
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CIMETIDINE HYDROCHLORIDE EQ 240MG BASE/100ML INJECTABLE;INJECTION Discontinued None No No
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CIMETIDINE HYDROCHLORIDE EQ 90MG BASE/100ML INJECTABLE;INJECTION Discontinued None No No
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CIMETIDINE HYDROCHLORIDE EQ 120MG BASE/100ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/29/1994 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
02/27/2001 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/05/1996 SUPPL-4 Labeling

Label is not available on this site.

12/22/1995 SUPPL-3 Labeling

Label is not available on this site.

07/22/1996 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/03/1996 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

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