Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 203803
Company: MYLAN
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 04/29/2016 | 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-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
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 | 205268 | GLENMARK PHARMS LTD |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203803 | MYLAN |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078540 | PAR PHARM |
| 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 | 202688 | WATSON LABS INC |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205956 | WILSHIRE PHARMS INC |
| RYTHMOL SR | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021416 | GLAXOSMITHKLINE LLC |
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 | 205268 | GLENMARK PHARMS LTD |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203803 | MYLAN |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078540 | PAR PHARM |
| 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 | 202688 | WATSON LABS INC |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205956 | WILSHIRE PHARMS INC |
| RYTHMOL SR | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021416 | GLAXOSMITHKLINE LLC |
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 | 205268 | GLENMARK PHARMS LTD |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203803 | MYLAN |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078540 | PAR PHARM |
| 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 | 202688 | WATSON LABS INC |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205956 | WILSHIRE PHARMS INC |
| RYTHMOL SR | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021416 | GLAXOSMITHKLINE LLC |
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