Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085595
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/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 |
|---|---|---|---|---|---|---|---|
| 03/26/1979 | 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-87 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/02/1999 | SUPPL-85 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 11/18/1998 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/10/1997 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/05/1996 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/01/1994 | SUPPL-77 | Labeling |
Label is not available on this site. |
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| 09/01/1994 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1994 | SUPPL-75 | Labeling |
Label is not available on this site. |
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| 12/01/1992 | SUPPL-74 | Labeling |
Label is not available on this site. |
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| 03/18/1991 | SUPPL-73 | Labeling |
Label is not available on this site. |
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| 11/13/1989 | SUPPL-72 | Labeling |
Label is not available on this site. |
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| 01/23/1989 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/21/1989 | SUPPL-68 | Labeling |
Label is not available on this site. |
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| 12/30/1988 | SUPPL-66 | Bioequivalence |
Label is not available on this site. |
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| 06/16/1986 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/16/1984 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/16/1984 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/10/1983 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |