Details for New Drug Application (NDA): 022442
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NDA 022442 describes REZIRA, which is a drug marketed by Persion and is included in one NDA. Additional details are available on the REZIRA profile page.
The generic ingredient in REZIRA 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 REZIRA 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 022442
| Tradename: | REZIRA |
| Applicant: | Persion |
| 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| SOLUTION;ORAL | Strength | 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 8, 2011 | TE: | RLD: | Yes | |||||
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