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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 204575


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NDA 204575 describes HYDROCODONE BITARTRATE AND IBUPROFEN, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Strides Pharma, Sun Pharm Inds Inc, and Teva, and is included in seven NDAs. It is available from 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-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate; ibuprofen profile page.
Summary for 204575
Tradename:HYDROCODONE BITARTRATE AND IBUPROFEN
Applicant:Aurolife Pharma Llc
Ingredient:hydrocodone bitartrate; ibuprofen
Patents:0
Pharmacology for NDA: 204575
Mechanism of ActionCyclooxygenase Inhibitors
Opioid Agonists
Suppliers and Packaging for NDA: 204575
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 204575 ANDA Aurolife Pharma, LLC 13107-004 13107-004-01 100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01)
HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 204575 ANDA Aurolife Pharma, LLC 13107-004 13107-004-05 500 TABLET, FILM COATED in 1 BOTTLE (13107-004-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG;200MG
Approval Date:Jun 2, 2016TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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