Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089537
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 500MG/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 |
---|---|---|---|---|---|---|---|
07/29/2004 | 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 |
---|---|---|---|---|---|
02/14/2001 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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12/22/1995 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/26/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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11/30/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/06/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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02/03/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |