Details for New Drug Application (NDA): 076550
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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 076550
Tradename: | PROPAFENONE HYDROCHLORIDE |
Applicant: | Ani Pharms |
Ingredient: | propafenone hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 076550
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 076550 | ANDA | A-S Medication Solutions | 50090-4227 | 50090-4227-0 | 60 TABLET, COATED in 1 BOTTLE (50090-4227-0) |
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 076550 | ANDA | Golden State Medical Supply, Inc. | 51407-015 | 51407-015-01 | 100 TABLET, COATED in 1 BOTTLE (51407-015-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Apr 23, 2004 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 225MG | ||||
Approval Date: | Apr 23, 2004 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Apr 23, 2004 | TE: | AB | RLD: | No |
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