Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076550
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | AB | No | No |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET;ORAL | Prescription | AB | No | No |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 300MG | TABLET;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 |
---|---|---|---|---|---|---|---|
04/23/2004 | 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 |
---|---|---|---|---|---|
10/30/2019 | SUPPL-11 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
PROPAFENONE HYDROCHLORIDE
TABLET;ORAL; 150MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 076550 | ANI PHARMS |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 202445 | AUROBINDO PHARMA |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 075938 | STRIDES PHARMA |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 075203 | WATSON LABS |
TABLET;ORAL; 225MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET;ORAL | Prescription | No | AB | 076550 | ANI PHARMS |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET;ORAL | Prescription | No | AB | 202445 | AUROBINDO PHARMA |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET;ORAL | Prescription | No | AB | 075938 | STRIDES PHARMA |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET;ORAL | Prescription | No | AB | 075203 | WATSON LABS |
TABLET;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 076550 | ANI PHARMS |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 202445 | AUROBINDO PHARMA |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 075938 | STRIDES PHARMA |