Details for New Drug Application (NDA): 210263
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NDA 210263 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 210263
| Tradename: | BIMATOPROST |
| Applicant: | Alembic |
| Ingredient: | bimatoprost |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210263
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BIMATOPROST | bimatoprost | SOLUTION/DROPS;OPHTHALMIC | 210263 | ANDA | Alembic Pharmaceuticals Limited | 46708-507 | 46708-507-05 | 1 BOTTLE in 1 CARTON (46708-507-05) / 5 mL in 1 BOTTLE |
| BIMATOPROST | bimatoprost | SOLUTION/DROPS;OPHTHALMIC | 210263 | ANDA | Alembic Pharmaceuticals Limited | 46708-507 | 46708-507-25 | 1 BOTTLE in 1 CARTON (46708-507-25) / 2.5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.03% | ||||
| Approval Date: | Apr 12, 2019 | TE: | AT | RLD: | No | ||||
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