Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088734
Company: PLIVA
Company: PLIVA
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 |
---|---|---|---|---|---|---|---|
12/11/1985 | 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 |
---|---|---|---|---|---|
07/07/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/29/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/03/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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06/04/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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06/04/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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06/04/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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06/04/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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03/22/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
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07/23/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |