.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Obtain formulation and manufacturing information
  • Set up watchlists for daily email updates

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
Merck
AstraZeneca
Boehringer Ingelheim
US Army
Citi
Harvard Business School
Fuji
UBS

Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203803

« Back to Dashboard
NDA 203803 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 seventeen 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. Nineteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.

Summary for NDA: 203803

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203803

Suppliers and Packaging for NDA: 203803

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPAFENONE HYDROCHLORIDE
propafenone hydrochloride
 CAPSULE, EXTENDED RELEASE;ORAL 203803 ANDA Mylan Pharmaceuticals Inc. 0378-1258 0378-1258-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1258-05)
PROPAFENONE HYDROCHLORIDE
propafenone hydrochloride
 CAPSULE, EXTENDED RELEASE;ORAL 203803 ANDA Mylan Pharmaceuticals Inc. 0378-1258 0378-1258-91 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1258-91)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength225MG
Approval Date:Apr 29, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength325MG
Approval Date:Apr 29, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength425MG
Approval Date:Apr 29, 2016TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKesson
Chubb
Covington
US Army
Mallinckrodt
Dow
Fish and Richardson
Colorcon
UBS
Merck

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Related Products from thinkBiotech
Links

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot