Details for New Drug Application (NDA): 202445
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The generic ingredient in PROPAFENONE HYDROCHLORIDE is propafenone hydrochloride. There are eleven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
Summary for 202445
Tradename: | PROPAFENONE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | propafenone hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 202445
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 202445 | ANDA | Aurobindo Pharma Limited | 59651-256 | 59651-256-01 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-256-01) |
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 202445 | ANDA | Aurobindo Pharma Limited | 59651-256 | 59651-256-33 | 300 TABLET, FILM COATED in 1 BOTTLE (59651-256-33) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | May 11, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 225MG | ||||
Approval Date: | May 11, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | May 11, 2016 | TE: | AB | RLD: | No |
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