Details for New Drug Application (NDA): 012575
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NDA 012575 describes ACTIFED W/ CODEINE, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the ACTIFED W/ CODEINE profile page.
The generic ingredient in ACTIFED W/ CODEINE is codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.
The generic ingredient in ACTIFED W/ CODEINE is codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.
Summary for 012575
| Tradename: | ACTIFED W/ CODEINE |
| Applicant: | Glaxosmithkline |
| Ingredient: | codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride |
| Patents: | 0 |
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 10MG/5ML;30MG/5ML;1.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 4, 1984 | TE: | RLD: | No | |||||
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