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 Dr Reddys Labs Sa, Esjay Pharma, Lgm Pharma, Stevens J, 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. Five suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine; 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. Five suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine; codeine phosphate profile page.
Summary for 203335
| Tradename: | BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | aspirin; butalbital; caffeine; codeine phosphate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 325MG;50MG;40MG;30MG | ||||
| Approval Date: | Oct 30, 2015 | TE: | RLD: | No | |||||
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