.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

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

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091633

« Back to Dashboard
NDA 091633 describes HYDROCODONE BITARTRATE AND IBUPROFEN, which is a drug marketed by Actavis Labs Fl Inc, Teva, Vintage Pharms, Sun Pharm Inds Inc, Amneal Pharms Ny, and Aurolife Pharma Llc, and is included in eight NDAs. It is available from twenty-three suppliers. Additional details are available on the HYDROCODONE BITARTRATE AND IBUPROFEN profile page.

The generic ingredient in HYDROCODONE BITARTRATE AND IBUPROFEN is hydrocodone bitartrate; ibuprofen. There are twenty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate; ibuprofen profile page.

Summary for NDA: 091633

Tradename:
HYDROCODONE BITARTRATE AND IBUPROFEN
Applicant:
Sun Pharm Inds Inc
Ingredient:
hydrocodone bitartrate; ibuprofen
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 091633

Suppliers and Packaging for NDA: 091633

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND IBUPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL 091633 ANDA Sun Pharmaceutical Industries, Inc. 57664-102 57664-102-08 100 TABLET, FILM COATED in 1 BOTTLE (57664-102-08)
HYDROCODONE BITARTRATE AND IBUPROFEN
hydrocodone bitartrate; ibuprofen
TABLET;ORAL 091633 ANDA Sun Pharmaceutical Industries, Inc. 57664-102 57664-102-13 500 TABLET, FILM COATED in 1 BOTTLE (57664-102-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;200MG
Approval Date:May 28, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;200MG
Approval Date:May 28, 2013TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG;200MG
Approval Date:May 28, 2013TE: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

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.

`abc