Details for New Drug Application (NDA): 210458
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NDA 210458 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 nine 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the travoprost profile page.
Summary for 210458
| Tradename: | TRAVOPROST |
| Applicant: | Alembic |
| Ingredient: | travoprost |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210458
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRAVOPROST | travoprost | SOLUTION/DROPS;OPHTHALMIC | 210458 | ANDA | Alembic Pharmaceuticals Inc. | 62332-510 | 62332-510-05 | 1 BOTTLE in 1 CARTON (62332-510-05) / 5 mL in 1 BOTTLE |
| TRAVOPROST | travoprost | SOLUTION/DROPS;OPHTHALMIC | 210458 | ANDA | Alembic Pharmaceuticals Inc. | 62332-510 | 62332-510-25 | 1 BOTTLE in 1 CARTON (62332-510-25) / 2.5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.004% | ||||
| Approval Date: | Dec 20, 2019 | TE: | AT1 | RLD: | No | ||||
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