Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087128
Company: APNAR PHARMA LP
Company: APNAR PHARMA LP
| 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 |
| 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 |
|---|---|---|---|---|---|---|---|
| 06/03/1981 | 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 |
|---|---|---|---|---|---|
| 07/07/2021 | SUPPL-33 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/28/2012 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/05/1998 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 02/18/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1988 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 07/16/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1982 | SUPPL-3 | 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 |
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 |