Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202688
Company: WATSON LABS INC
Company: WATSON LABS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 08/24/2015 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202688Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202688Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/30/2019 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/24/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202688Orig1s000lbl.pdf |
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 | 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 | 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 | 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 |