Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS MID ATLANTIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROMETH PLAIN | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;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 |
---|---|---|---|---|---|---|---|
08/21/1978 | 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 |
---|---|---|---|---|---|
10/03/2001 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/03/2001 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/13/2001 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/20/2000 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/17/1999 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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06/17/1999 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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08/04/1997 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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01/16/1997 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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07/05/1996 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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08/08/1996 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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08/08/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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08/08/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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08/08/1996 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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10/30/1997 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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10/30/1997 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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06/04/1993 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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09/28/1990 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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12/27/1990 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/1990 | SUPPL-22 | Labeling |
Label is not available on this site. |
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05/01/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
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11/21/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
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05/16/1990 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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02/08/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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02/08/1989 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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02/12/1986 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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04/05/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/25/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |