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Details for New Drug Application (NDA): 075938

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NDA 075938 describes PROPAFENONE HYDROCHLORIDE, which is a drug marketed by Mylan Pharms Inc, Watson Labs, Vintage Pharms, Par Pharm, Orion Corp Orion, Ani Pharms Inc, Watson Labs Inc, Nesher Pharms, and Sun Pharm Inds, and is included in nine NDAs. It is available from eighteen suppliers. Additional details are available on the PROPAFENONE HYDROCHLORIDE profile page.

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 NDA: 075938

Tradename:
PROPAFENONE HYDROCHLORIDE
Applicant:
Vintage Pharms
Ingredient:
propafenone hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075938

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 Qualitest Pharmaceuticals 0603-5448 0603-5448-21 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5448-21)
PROPAFENONE HYDROCHLORIDE
propafenone hydrochloride
TABLET;ORAL 075938 ANDA Qualitest Pharmaceuticals 0603-5448 0603-5448-25 300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5448-25)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Oct 17, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength225MG
Approval Date:Oct 17, 2002TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 17, 2002TE:ABRLD:No


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