Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074269
Company: HOSPIRA
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 6MG BASE/ML | 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 |
---|---|---|---|---|---|---|---|
12/27/1994 | 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 |
---|---|---|---|---|---|
12/01/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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06/02/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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04/17/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
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03/12/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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08/24/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
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07/03/1996 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/16/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |