Details for New Drug Application (NDA): 075998
✉ Email this page to a colleague
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 075998
Tradename: | PROPAFENONE HYDROCHLORIDE |
Applicant: | Sun Pharm Industries |
Ingredient: | propafenone hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 075998
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 075998 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-551 | 53489-551-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-551-01) |
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 075998 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-551 | 53489-551-03 | 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-551-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Nov 29, 2001 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 225MG | ||||
Approval Date: | Nov 29, 2001 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Nov 29, 2001 | TE: | RLD: | No |
Complete Access Available with Subscription