Details for New Drug Application (NDA): 205658
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NDA 205658 describes HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Mayne Pharma Inc, Padagis Us, Sciegen Pharms Inc, and Tris Pharma Inc, and is included in four NDAs. Additional details are available on the HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.
The generic ingredient in HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE is hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Additional details are available on the hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.
The generic ingredient in HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE is hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Additional details are available on the hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.
Summary for 205658
| Tradename: | HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
| Applicant: | Mayne Pharma Inc |
| Ingredient: | hydrocodone bitartrate; pseudoephedrine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML;60MG/5ML | ||||
| Approval Date: | Nov 17, 2015 | TE: | RLD: | No | |||||
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