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Details for New Drug Application (NDA): 201013

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NDA 201013 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, Vistapharm, Allergan Sales Llc, 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 three NDAs. It is available from seventy-eight 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 suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for NDA: 201013

Tradename:
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Applicant:
Aurolife Pharma Llc
Ingredient:
acetaminophen; hydrocodone bitartrate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 201013

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 201013

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
TABLET;ORAL 201013 ANDA Aurolife Pharma LLC 13107-019 13107-019-01 100 TABLET in 1 BOTTLE (13107-019-01)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
TABLET;ORAL 201013 ANDA Aurolife Pharma LLC 13107-019 13107-019-05 500 TABLET in 1 BOTTLE (13107-019-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Apr 11, 2012TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Apr 11, 2012TE:AARLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;10MG
Approval Date:Apr 11, 2012TE:AARLD:No


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