Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074610
Company: ANI PHARMS
Company: ANI PHARMS
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 |
---|---|---|---|---|---|---|---|
09/26/1996 | 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 |
---|---|---|---|---|---|
08/30/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/07/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/24/2000 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/28/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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10/14/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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04/07/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |