Drugs@FDA: FDA-Approved Drugs
Company: INVATECH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/19/1975 | 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 |
|---|---|---|---|---|---|
| 06/19/2007 | SUPPL-106 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/2002 | SUPPL-100 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/22/2002 | SUPPL-99 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/18/2001 | SUPPL-98 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/05/1999 | SUPPL-97 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/11/1999 | SUPPL-96 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/11/1999 | SUPPL-95 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/11/1999 | SUPPL-94 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/11/1999 | SUPPL-93 | Labeling |
Label is not available on this site. |
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| 11/07/1995 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/23/1996 | SUPPL-90 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1989 | SUPPL-87 | Labeling |
Label is not available on this site. |
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| 04/24/1986 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/28/1987 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/01/1985 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1984 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1984 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1984 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1984 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1984 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/25/1984 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/11/1982 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1982 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1982 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1982 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1982 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1982 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1982 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
MECLIZINE HYDROCHLORIDE
TABLET;ORAL; 25MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANTIVERT | MECLIZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | Yes | AA | 010721 | CASPER PHARMA LLC |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 201451 | AMNEAL PHARMS |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 087128 | APNAR PHARMA LP |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 202640 | AUROBINDO PHARMA USA |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 203003 | CHARTWELL RX |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 200294 | EPIC PHARMA LLC |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 084092 | INVATECH |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 040659 | JUBILANT CADISTA |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 205136 | WILSHIRE PHARMS INC |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 213957 | ZYDUS LIFESCIENCES |