Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080968
Company: WATSON LABS
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
05/03/1973 | 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 |
---|---|---|---|---|---|
04/17/1996 | SUPPL-27 | Labeling |
Label is not available on this site. |
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02/09/1994 | SUPPL-26 | Labeling |
Label is not available on this site. |
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02/05/1991 | SUPPL-25 | Labeling |
Label is not available on this site. |
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06/15/1990 | SUPPL-24 | Labeling |
Label is not available on this site. |
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08/12/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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01/28/1991 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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05/31/1991 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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04/09/1990 | SUPPL-20 | Labeling |
Label is not available on this site. |