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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203335


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NDA 203335 describes BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, which is a drug marketed by Mayne Pharma Inc, Nexgen Pharma Inc, Stevens J, Vintage Pharms Llc, and Watson Labs, and is included in five NDAs. It is available from five suppliers. Additional details are available on the BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE profile page.

The generic ingredient in BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 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.
Suppliers and Packaging for NDA: 203335
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE aspirin; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 203335 ANDA Mayne Pharma Inc. 68308-312 68308-312-10 100 CAPSULE in 1 BOTTLE (68308-312-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength325MG;50MG;40MG;30MG
Approval Date:Oct 30, 2015TE:ABRLD:No

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