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Details for New Drug Application (NDA): 040894

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NDA 040894 describes HYDROCODONE BITARTRATE AND ACETAMINOPHEN, which is a drug marketed by Mallinckrodt, Par Pharm, Barr, Mikart, Mallinckrodt Inc, Ucb Inc, Amneal Pharms Ny, Aurolife Pharma Llc, Tris Pharma Inc, Vintage Pharms, Sun Pharm Inds Inc, Ranbaxy Labs Ltd, Watson Labs, Ranbaxy, Sun Pharm Inds Ltd, Pharm Assoc, Larken Labs Inc, Mutual Pharm, Amneal Pharms, Novel Labs Inc, Vistapharm, Apil, Sandoz, Halsey, Able, Caraco, Nesher Pharms, Actavis Labs Fl Inc, Vintage Pharms Llc, Usl Pharma, Rhodes Pharms, Watson Labs Florida, and Ivax Pharms, and is included in one hundred and six NDAs. It is available from eighty-two suppliers. Additional details are available on the HYDROCODONE BITARTRATE AND ACETAMINOPHEN profile page.

The generic ingredient in HYDROCODONE BITARTRATE AND ACETAMINOPHEN is acetaminophen; hydrocodone bitartrate. There are sixty-five drug master file entries for this compound. Eighty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for NDA: 040894

Formulation / Manufacturing:see details

Pharmacology for NDA: 040894

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 040894

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
acetaminophen; hydrocodone bitartrate
SOLUTION;ORAL 040894 ANDA Atlantic Biologicals Corps 17856-0640 17856-0640-2 15 mL in 1 CUP, UNIT-DOSE (17856-0640-2)
acetaminophen; hydrocodone bitartrate
SOLUTION;ORAL 040894 ANDA Physicians Total Care, Inc. 54868-6437 54868-6437-0 118 mL in 1 BOTTLE (54868-6437-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength325MG/15ML;7.5MG/15ML
Approval Date:Jul 19, 2011TE:AARLD:No

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