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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078569

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NDA 078569 describes ACETAMINOPHEN, which is a drug marketed by Custopharm Inc, Fresenius Kabi Usa, Sandoz Inc, Able, Acino Prods, Perrigo New York, Taro Pharms North, Aurobindo Pharma Ltd, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Teva, Actavis Mid Atlantic, Allied Pharma Inc, Dava Pharms Inc, Hi Tech Pharma, Mikart, Pharm Assoc, Vintage Pharms, Wockhardt, Am Therap, Amneal Pharms Ny, Anda Repository, Aurolife Pharma Llc, Duramed Pharms Barr, Everylife, Halsey, Kv Pharm, Lederle, Mallinckrodt Inc, Mutual Pharm, Puracap Pharm, Purepac Pharm, Roxane, Sandoz, Superpharm, Usl Pharma, Valeant Pharm Intl, Vintage, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Whiteworth Town Plsn, Cent Pharms, Gavis Pharms, Larken Labs Inc, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp, and is included in one hundred and eighteen NDAs. It is available from sixty-five suppliers. Additional details are available on the ACETAMINOPHEN profile page.

The generic ingredient in ACETAMINOPHEN is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.

Summary for 078569

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078569

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN acetaminophen TABLET, EXTENDED RELEASE;ORAL 078569 ANDA Walgreen Company 0363-0340 0363-0340-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0363-0340-01)
ACETAMINOPHEN acetaminophen TABLET, EXTENDED RELEASE;ORAL 078569 ANDA Walgreen Company 0363-0340 0363-0340-80 80 TABLET, EXTENDED RELEASE in 1 BOTTLE (0363-0340-80)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength650MG
Approval Date:Dec 14, 2011TE:RLD:No


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