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Details for NDA: 073107

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NDA 073107 describes ACETAMINOPHEN, which is a drug marketed by Able, Perrigo New York, Roxane, Taro Pharms North, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Teva, Actavis Mid Atlantic, Dava Pharms Inc, Hi Tech Pharma, Mikart, Pharm Assoc, Vintage Pharms, Wockhardt, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Everylife, Halsey, Kv Pharm, Lederle, Mallinckrodt Inc, Mutual Pharm, Puracap Pharm, Purepac Pharm, Sandoz, Superpharm, Usl Pharma, Valeant Pharm Intl, Vintage, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Whiteworth Town Plsn, Cent Pharms, Gavis Pharms, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp, and is included in one hundred and twelve NDAs. It is available from two suppliers. Additional details are available on the ACETAMINOPHEN profile page.

The generic ingredient in ACETAMINOPHEN is acetaminophen; pentazocine hydrochloride. There are sixty-four drug master file entries for this compound. Additional details are available on the acetaminophen; pentazocine hydrochloride profile page.

Summary for NDA: 073107


Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUPPOSITORY; RECTALStrength325MG
Approval Date:Feb 27, 1995TE:RLD:No

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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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