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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Boehringer Ingelheim
Daiichi Sankyo
Express Scripts
Johnson and Johnson
Queensland Health

Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075998

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NDA 075998 describes PROPAFENONE HYDROCHLORIDE, which is a drug marketed by Mylan Pharms Inc, Watson Labs, Vintage Pharms, Par Pharm, Orion Corp Orion, Ani Pharms Inc, Glenmark Pharms Ltd, Watson Labs Inc, Nesher Pharms, and Sun Pharm Inds, and is included in ten 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: 075998

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075998

Suppliers and Packaging for NDA: 075998

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
propafenone hydrochloride
TABLET;ORAL 075998 ANDA Mylan Institutional Inc. 51079-996 51079-996-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-996-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-996-01)
propafenone hydrochloride
TABLET;ORAL 075998 ANDA Mutual Pharmaceutical Co., Inc. 53489-551 53489-551-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-551-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Nov 29, 2001TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength225MG
Approval Date:Nov 29, 2001TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Nov 29, 2001TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Argus Health
Daiichi Sankyo
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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