Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | 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 |
---|---|---|---|---|---|---|---|
07/06/1977 | 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 |
---|---|---|---|---|---|
04/13/1999 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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04/13/1999 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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03/25/1998 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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03/25/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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05/23/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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03/28/1989 | SUPPL-23 | Bioequivalence |
Label is not available on this site. |
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04/18/1989 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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04/18/1989 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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04/18/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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05/09/1988 | SUPPL-18 | Labeling |
Label is not available on this site. |
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06/24/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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06/24/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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05/10/1982 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/10/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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05/10/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/10/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |