Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209587

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NDA 209587 describes BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, which is a drug marketed by Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Hikma Pharms, Mallinckrodt, Mayne Pharma Inc, Nexgen Pharma, Nuvo Pharms Inc, Wraser Pharms Llc, Mikart, Abhai Llc, Able, Actavis Labs Ut Inc, Cnty Line Pharms, Lannett Co Inc, Mirror Pharms Llc, Nexgen Pharma Inc, Novast Labs, Specgx Llc, Sun Pharm Industries, Vintage Pharms, and Watson Labs, and is included in thirty-two NDAs. It is available from thirty-seven 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-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 209587
Pharmacology for NDA: 209587
Suppliers and Packaging for NDA: 209587
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 209587 ANDA Nexgen Pharma, Inc. 0722-7320 0722-7320-01 100 TABLET in 1 BOTTLE (0722-7320-01)
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 209587 ANDA Nexgen Pharma, Inc. 0722-7320 0722-7320-05 500 TABLET in 1 BOTTLE (0722-7320-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG;40MG
Approval Date:Oct 31, 2018TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
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Moodys

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