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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Last Updated: December 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019429

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NDA 019429 describes FIORINAL W/CODEINE, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the FIORINAL W/CODEINE profile page.

The generic ingredient in FIORINAL W/CODEINE is aspirin; butalbital; caffeine; codeine phosphate. There are twenty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine; codeine phosphate profile page.
Summary for 019429
Suppliers and Packaging for NDA: 019429
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FIORINAL W/CODEINE aspirin; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 019429 NDA Allergan, Inc. 0023-6010 0023-6010-01 100 CAPSULE in 1 BOTTLE (0023-6010-01)
FIORINAL W/CODEINE aspirin; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 019429 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-3546 0591-3546-01 100 CAPSULE in 1 BOTTLE (0591-3546-01)

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength325MG;50MG;40MG;30MG
Approval Date:Oct 26, 1990TE:ABRLD:Yes

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