Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078540
Company: STRIDES PHARMA
Company: STRIDES PHARMA
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/18/2010 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078540s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078540Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/10/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
10/18/2010 | SUPPL-3 |
Label is not available on this site. |
|||
07/11/2011 | SUPPL-2 | 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 | 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 PHARMA |
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 PHARMA |
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 PHARMA |
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 |