Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084843
Company: SANDOZ
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. |
||
| 03/25/2002 | SUPPL-97 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/2001 | SUPPL-96 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-95 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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. |
||
| 03/12/1999 | SUPPL-92 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-91 | Labeling |
Label is not available on this site. |
||
| 11/07/1995 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1996 | SUPPL-88 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1989 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 03/21/1986 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/1985 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1985 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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. |
||
| 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 | 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 | 087128 | SENORES PHARMS |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AA | 213957 | ZYDUS LIFESCIENCES |