Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087601
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMINOPHYLLINE | AMINOPHYLLINE | 25MG/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 |
---|---|---|---|---|---|---|---|
07/23/1982 | 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-11 | Manufacturing (CMC) |
Label is not available on this site. |
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12/31/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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10/29/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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10/29/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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04/13/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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01/03/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
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04/01/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/10/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |