Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085597
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 20MG/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 |
|---|---|---|---|---|---|---|---|
| 03/14/1979 | 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-37 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/02/1999 | SUPPL-35 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 11/18/1998 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/10/1997 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/13/1996 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 06/13/1996 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/13/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1994 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 12/01/1992 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 03/18/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 11/21/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 11/29/1988 | SUPPL-24 | Bioequivalence |
Label is not available on this site. |
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| 12/28/1988 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 12/28/1988 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 06/16/1986 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1984 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1984 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/25/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |