Details for New Drug Application (NDA): 022279
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NDA 022279 describes HYCOFENIX, which is a drug marketed by Chartwell Rx and is included in one NDA. Additional details are available on the HYCOFENIX profile page.
The generic ingredient in HYCOFENIX is guaifenesin; hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Additional details are available on the guaifenesin; hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.
The generic ingredient in HYCOFENIX is guaifenesin; hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Additional details are available on the guaifenesin; hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.
Summary for 022279
| Tradename: | HYCOFENIX |
| Applicant: | Chartwell Rx |
| Ingredient: | guaifenesin; hydrocodone bitartrate; pseudoephedrine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 200MG/5ML;2.5MG/5ML;30MG/5ML | ||||
| Approval Date: | May 14, 2015 | TE: | RLD: | Yes | |||||
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