Details for New Drug Application (NDA): 216472
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NDA 216472 describes IYUZEH, which is a drug marketed by Thea Pharma and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the IYUZEH profile page.
The generic ingredient in IYUZEH is latanoprost. There are twenty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.
The generic ingredient in IYUZEH is latanoprost. There are twenty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.
Summary for 216472
| Tradename: | IYUZEH |
| Applicant: | Thea Pharma |
| Ingredient: | latanoprost |
| Patents: | 1 |
Suppliers and Packaging for NDA: 216472
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IYUZEH | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 216472 | NDA | Thea Pharma Inc. | 82584-003 | 82584-003-30 | 30 POUCH in 1 CARTON (82584-003-30) / .2 mL in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.005% | ||||
| Approval Date: | Dec 13, 2022 | TE: | RLD: | Yes | |||||
| Patent: | 8,637,054 | Patent Expiration: | Jul 8, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF OCULAR HYPERTENSION AND GLAUCOMA | ||||||||
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