Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083398
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISOLONE ACETATE | PREDNISOLONE ACETATE | 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 |
|---|---|---|---|---|---|---|---|
| 02/13/1974 | 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 |
|---|---|---|---|---|---|
| 02/19/1999 | SUPPL-143 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/02/1999 | SUPPL-142 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 05/27/1998 | SUPPL-141 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/06/1997 | SUPPL-140 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1991 | SUPPL-138 | Labeling |
Label is not available on this site. |
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| 10/26/1989 | SUPPL-137 | Labeling |
Label is not available on this site. |
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| 01/11/1991 | SUPPL-136 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/11/1991 | SUPPL-135 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1988 | SUPPL-134 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1988 | SUPPL-133 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/30/1988 | SUPPL-131 | Bioequivalence |
Label is not available on this site. |
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| 06/16/1986 | SUPPL-130 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/31/1984 | SUPPL-129 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/27/1984 | SUPPL-126 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/27/1984 | SUPPL-125 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/27/1984 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |