Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074344
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CIMETIDINE HYDROCHLORIDE | CIMETIDINE HYDROCHLORIDE | EQ 300MG BASE/2ML | 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 |
---|---|---|---|---|---|---|---|
01/31/1995 | 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 |
---|---|---|---|---|---|
10/25/2002 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/22/2001 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/22/2001 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/07/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
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01/07/2000 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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07/26/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
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10/03/1996 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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12/22/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |