Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
02/03/1976 | 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 |
---|---|---|---|---|---|
05/15/2002 | SUPPL-98 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/25/2002 | SUPPL-97 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/26/2001 | SUPPL-96 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/05/1999 | SUPPL-95 | Manufacturing (CMC) |
Label is not available on this site. |
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03/12/1999 | SUPPL-94 | Manufacturing (CMC) |
Label is not available on this site. |
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03/12/1999 | SUPPL-93 | Manufacturing (CMC) |
Label is not available on this site. |
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03/12/1999 | SUPPL-92 | Manufacturing (CMC) |
Label is not available on this site. |
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03/12/1999 | SUPPL-91 | Labeling |
Label is not available on this site. |
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11/07/1995 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
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02/07/1996 | SUPPL-88 | Manufacturing (CMC) |
Label is not available on this site. |
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05/22/1989 | SUPPL-85 | Labeling |
Label is not available on this site. |
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03/21/1986 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
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07/05/1985 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
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03/01/1985 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
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04/12/1984 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
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04/12/1984 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
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01/25/1984 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
MECLIZINE HYDROCHLORIDE
TABLET;ORAL; 12.5MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ANTIVERT | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | Yes | AA | 010721 | CASPER PHARMA LLC |
MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AA | 201451 | AMNEAL PHARMS |
MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AA | 087128 | APNAR PHARMA LP |
MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AA | 202640 | AUROBINDO PHARMA USA |
MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AA | 203003 | CHARTWELL RX |
MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AA | 200294 | EPIC PHARMA LLC |
MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AA | 040659 | JUBILANT CADISTA |
MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AA | 084843 | SANDOZ |
MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AA | 205136 | WILSHIRE PHARMS INC |
MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AA | 213957 | ZYDUS LIFESCIENCES |