Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084315
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXAMETHASONE ACETATE | DEXAMETHASONE ACETATE | EQ 8MG BASE/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 |
|---|---|---|---|---|---|---|---|
| 11/08/1978 | 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 |
|---|---|---|---|---|---|
| 12/02/2014 | SUPPL-118 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/1999 | SUPPL-116 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-115 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/22/1998 | SUPPL-114 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1995 | SUPPL-113 | Labeling |
Label is not available on this site. |
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| 03/21/1994 | SUPPL-112 | Labeling |
Label is not available on this site. |
||
| 12/20/1993 | SUPPL-111 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1992 | SUPPL-110 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/08/1989 | SUPPL-109 | Labeling |
Label is not available on this site. |
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| 03/19/1991 | SUPPL-108 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/19/1991 | SUPPL-107 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1988 | SUPPL-105 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1988 | SUPPL-104 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/16/1986 | SUPPL-98 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/25/1983 | SUPPL-95 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/15/1982 | SUPPL-93 | Manufacturing (CMC) |
Label is not available on this site. |