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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200243


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NDA 200243 describes BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, which is a drug marketed by Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Granules Pharms, Hikma Pharms, Lannett Co Inc, Mallinckrodt, Mayne Pharma Inc, Nexgen Pharma, Nuvo Pharms Inc, Wraser Pharms Llc, Mikart, Abhai Llc, Able, Actavis Labs Ut Inc, Cnty Line Pharms, Mirror Pharms Llc, Nexgen Pharma Inc, Novast Labs, Specgx Llc, Sun Pharm Industries, Vintage Pharms, and Watson Labs, and is included in thirty-six NDAs. It is available from thirty-two suppliers. Additional details are available on the BUTALBITAL, ACETAMINOPHEN AND CAFFEINE profile page.

The generic ingredient in BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is acetaminophen; butalbital; caffeine. There are sixty-six drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 200243
Pharmacology for NDA: 200243
Suppliers and Packaging for NDA: 200243
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 200243 ANDA Lannett Company, Inc. 0527-1695 0527-1695-01 100 TABLET in 1 BOTTLE, PLASTIC (0527-1695-01)
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 200243 ANDA Lannett Company, Inc. 0527-1695 0527-1695-05 500 TABLET in 1 BOTTLE, PLASTIC (0527-1695-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG;40MG
Approval Date:Sep 13, 2012TE:AARLD:No

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