Details for New Drug Application (NDA): 090468
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NDA 090468 describes ZYFREL, which is a drug marketed by Cypress Pharm Inc and is included in one NDA. Additional details are available on the ZYFREL profile page.
The generic ingredient in ZYFREL is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
The generic ingredient in ZYFREL is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 090468
| Tradename: | ZYFREL |
| Applicant: | Cypress Pharm Inc |
| Ingredient: | acetaminophen; hydrocodone bitartrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 325MG/15ML;7.5MG/15ML | ||||
| Approval Date: | Apr 14, 2016 | TE: | RLD: | No | |||||
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