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Details for New Drug Application (NDA): 089990

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NDA 089990 describes ACETAMINOPHEN AND CODEINE PHOSPHATE, which is a drug marketed by Aurolife Pharma Llc, Vintage, Wockhardt, Warner Chilcott, Whiteworth Town Plsn, Pharm Assoc, Roxane, Everylife, Sandoz, Hi Tech Pharma, Mallinckrodt Inc, Usl Pharma, Duramed Pharms Barr, Teva, Vintage Pharms, Mikart, Lederle, Watson Labs Florida, Halsey, Able, Mutual Pharm, Superpharm, Actavis Mid Atlantic, Puracap Pharm, Kv Pharm, Sun Pharm Inds Ltd, Frontida Biopharm, Watson Labs, Vitarine, Am Therap, Amneal Pharms Ny, Purepac Pharm, Valeant Pharm Intl, and Dava Pharms Inc, and is included in ninety-one NDAs. It is available from fifty-two suppliers. Additional details are available on the ACETAMINOPHEN AND CODEINE PHOSPHATE profile page.

The generic ingredient in ACETAMINOPHEN AND CODEINE PHOSPHATE is acetaminophen; codeine phosphate. There are sixty-five drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for NDA: 089990

Tradename:
ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:
Vintage
Ingredient:
acetaminophen; codeine phosphate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 089990

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 089990

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
TABLET;ORAL 089990 ANDA Qualitest Pharmaceuticals 0603-2337 0603-2337-21 100 TABLET in 1 BOTTLE, PLASTIC (0603-2337-21)
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
TABLET;ORAL 089990 ANDA Qualitest Pharmaceuticals 0603-2337 0603-2337-28 500 TABLET in 1 BOTTLE, PLASTIC (0603-2337-28)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;15MG
Approval Date:Sep 30, 1988TE:AARLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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