Details for New Drug Application (NDA): 075938
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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 075938
Tradename: | PROPAFENONE HYDROCHLORIDE |
Applicant: | Strides Pharma |
Ingredient: | propafenone hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 075938
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 075938 | ANDA | American Health Packaging | 60687-709 | 60687-709-01 | 100 BLISTER PACK in 1 CARTON (60687-709-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-709-11) |
PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | TABLET;ORAL | 075938 | ANDA | Strides Pharma Science Limited | 64380-163 | 64380-163-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-163-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Oct 17, 2002 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 225MG | ||||
Approval Date: | Oct 17, 2002 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Oct 17, 2002 | TE: | AB | RLD: | No |
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