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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074251
Company: CHARTWELL MOLECULAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIMETIDINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION;ORAL 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
12/22/1994 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
06/10/2024 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

01/17/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1996 SUPPL-2 Labeling

Label is not available on this site.

11/09/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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