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Generated: August 17, 2017

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-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine; codeine phosphate profile page.

Summary for NDA: 019429

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

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)

Summary 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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