Details for New Drug Application (NDA): 217228
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NDA 217228 describes TRAVOPROST, which is a drug marketed by Alembic, Apotex, Chartwell Rx, Gland Pharma Ltd, Lupin Ltd, Micro Labs, Mylan, and Somerset Theraps Llc, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the TRAVOPROST profile page.
The generic ingredient in TRAVOPROST is travoprost. There are fifteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the travoprost profile page.
The generic ingredient in TRAVOPROST is travoprost. There are fifteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the travoprost profile page.
Summary for 217228
| Tradename: | TRAVOPROST |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | travoprost |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217228
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRAVOPROST | travoprost | SOLUTION/DROPS;OPHTHALMIC | 217228 | ANDA | Somerset Therapeutics, LLC | 70069-586 | 70069-586-01 | 1 BOTTLE in 1 CARTON (70069-586-01) / 2.5 mL in 1 BOTTLE |
| TRAVOPROST | travoprost | SOLUTION/DROPS;OPHTHALMIC | 217228 | ANDA | Somerset Therapeutics, LLC | 70069-587 | 70069-587-01 | 1 BOTTLE in 1 CARTON (70069-587-01) / 5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.004% | ||||
| Approval Date: | Sep 23, 2024 | TE: | AT | RLD: | No | ||||
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