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Last Updated: June 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210817

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NDA 210817 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-one 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-one suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 210817
Pharmacology for NDA: 210817
Suppliers and Packaging for NDA: 210817
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 210817 ANDA Mayne Pharma 51862-542 51862-542-01 100 CAPSULE in 1 BOTTLE, PLASTIC (51862-542-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG;50MG;40MG
Approval Date:Dec 17, 2019TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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