Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212744
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 06/25/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PROPAFENONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;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 | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213096 | AUROBINDO PHARMA LTD |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205268 | GLENMARK PHARMS LTD |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205956 | RISING |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210339 | SINOTHERAPEUTICS INC |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078540 | STRIDES PHARMA |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212928 | TWI PHARMS |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212744 | UPSHER SMITH LABS |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202688 | WATSON LABS INC |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214184 | ZYDUS LIFESCIENCES |
CAPSULE, EXTENDED RELEASE;ORAL; 325MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213096 | AUROBINDO PHARMA LTD |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205268 | GLENMARK PHARMS LTD |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205956 | RISING |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210339 | SINOTHERAPEUTICS INC |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078540 | STRIDES PHARMA |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212928 | TWI PHARMS |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212744 | UPSHER SMITH LABS |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202688 | WATSON LABS INC |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214184 | ZYDUS LIFESCIENCES |
CAPSULE, EXTENDED RELEASE;ORAL; 425MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213096 | AUROBINDO PHARMA LTD |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205268 | GLENMARK PHARMS LTD |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205956 | RISING |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210339 | SINOTHERAPEUTICS INC |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078540 | STRIDES PHARMA |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212928 | TWI PHARMS |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212744 | UPSHER SMITH LABS |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202688 | WATSON LABS INC |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214184 | ZYDUS LIFESCIENCES |