Details for New Drug Application (NDA): 207601
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NDA 207601 describes BIMATOPROST, which is a drug marketed by Alembic, Apotex, Eugia Pharma, Gland Pharma Ltd, Hikma, Lupin Ltd, Micro Labs, Sandoz, and Somerset Theraps Llc, and is included in thirteen NDAs. It is available from ten suppliers. Additional details are available on the BIMATOPROST profile page.
The generic ingredient in BIMATOPROST is bimatoprost. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.
The generic ingredient in BIMATOPROST is bimatoprost. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.
Summary for 207601
| Tradename: | BIMATOPROST |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | bimatoprost |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207601
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BIMATOPROST | bimatoprost | SOLUTION/DROPS;OPHTHALMIC | 207601 | ANDA | Somerset Therapeutics, LLC | 70069-401 | 70069-401-01 | 1 BOTTLE in 1 CARTON (70069-401-01) / 2.5 mL in 1 BOTTLE |
| BIMATOPROST | bimatoprost | SOLUTION/DROPS;OPHTHALMIC | 207601 | ANDA | Somerset Therapeutics, LLC | 70069-402 | 70069-402-01 | 1 BOTTLE in 1 CARTON (70069-402-01) / 5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.03% | ||||
| Approval Date: | Jun 19, 2019 | TE: | AT | RLD: | No | ||||
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