Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074450
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL | Prescription | AB | No | No |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL | Prescription | AB | No | No |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 05/16/1996 | 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 |
|---|---|---|---|---|---|
| 04/29/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/2000 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/16/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/1999 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/07/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/07/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
MEXILETINE HYDROCHLORIDE
CAPSULE;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL | Prescription | No | AB | 074450 | ANI PHARMS |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL | Prescription | No | AB | 216463 | ANNORA PHARMA |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL | Prescription | No | AB | 215876 | CHEMISTRY HLTH |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL | Prescription | No | AB | 213500 | CROSSMEDIKA SA |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL | Prescription | No | AB | 214352 | NOVAST LABS |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL | Prescription | No | AB | 214089 | SENORES PHARMS |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL | Prescription | No | AB | 074377 | TEVA |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL | Prescription | No | AB | 215315 | ZENARA |
CAPSULE;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 074450 | ANI PHARMS |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 216463 | ANNORA PHARMA |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 215876 | CHEMISTRY HLTH |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 213500 | CROSSMEDIKA SA |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 214352 | NOVAST LABS |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 214089 | SENORES PHARMS |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 074377 | TEVA |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 215315 | ZENARA |
CAPSULE;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 074450 | ANI PHARMS |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 216463 | ANNORA PHARMA |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 215876 | CHEMISTRY HLTH |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 213500 | CROSSMEDIKA SA |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 214352 | NOVAST LABS |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 214089 | SENORES PHARMS |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 074377 | TEVA |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 215315 | ZENARA |