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Last Updated: September 27, 2020

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Details for New Drug Application (NDA): 213321

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NDA 213321 describes BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, which is a drug marketed by Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Granules Pharms, Hikma, Lannett Co Inc, Mallinckrodt, Mayne Pharma Inc, Nexgen Pharma, Nuvo Pharms Inc, Taro Pharm Inds Ltd, Wraser Pharms Llc, Mikart, Abhai Llc, Able, Actavis Labs Ut Inc, Cnty Line Pharms, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Nexgen Pharma Inc, Novast Labs, Specgx Llc, Sun Pharm Industries, Vintage Pharms, and Watson Labs, and is included in thirty-eight NDAs. It is available from thirty-three 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-three suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 213321
Pharmacology for NDA: 213321
Suppliers and Packaging for NDA: 213321
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 213321 ANDA Granules Pharmaceuticals Inc. 70010-044 70010-044-01 100 CAPSULE in 1 BOTTLE (70010-044-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG;50MG;40MG
Approval Date:Apr 8, 2020TE:AARLD:No

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