Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS MID ATLANTIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACETASOL HC | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | 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 |
---|---|---|---|---|---|---|---|
01/13/1982 | 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 |
---|---|---|---|---|---|
12/29/2000 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/07/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
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10/26/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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11/17/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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06/06/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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05/13/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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06/04/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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09/28/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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01/09/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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12/15/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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07/17/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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01/13/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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09/08/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |