BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Julphar
Express Scripts
US Army
Chubb
Merck
Fuji
McKinsey
Cipla
Moodys
Novartis

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091633

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NDA 091633 describes HYDROCODONE BITARTRATE AND IBUPROFEN, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms Ny, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, and Vintage Pharms, and is included in eight NDAs. It is available from twenty-one 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-one suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate; ibuprofen profile page.
Summary for 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 57664-102-18 1000 TABLET, FILM COATED in 1 BOTTLE (57664-102-18)
HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 091633 ANDA Sun Pharmaceutical Industries, Inc. 57664-102 57664-102-88 100 TABLET, FILM COATED in 1 BOTTLE (57664-102-88)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG;200MG
Approval Date:May 28, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Fuji
Fish and Richardson
Dow
Citi
Cerilliant
Argus Health
Colorcon
Johnson and Johnson
Baxter

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