Details for New Drug Application (NDA): 086576
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NDA 086576 describes TYZINE, which is a drug marketed by Fougera Pharms and is included in one NDA. Additional details are available on the TYZINE profile page.
The generic ingredient in TYZINE is tetrahydrozoline hydrochloride. There are two drug master file entries for this compound. Additional details are available on the tetrahydrozoline hydrochloride profile page.
The generic ingredient in TYZINE is tetrahydrozoline hydrochloride. There are two drug master file entries for this compound. Additional details are available on the tetrahydrozoline hydrochloride profile page.
Summary for 086576
| Tradename: | TYZINE |
| Applicant: | Fougera Pharms |
| Ingredient: | tetrahydrozoline hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;NASAL | Strength | 0.1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;NASAL | Strength | 0.05% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 0.1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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