Details for New Drug Application (NDA): 210126
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The generic ingredient in BIMATOPROST is bimatoprost. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.
Summary for 210126
| Tradename: | BIMATOPROST |
| Applicant: | Gland |
| Ingredient: | bimatoprost |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210126
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BIMATOPROST | bimatoprost | SOLUTION/DROPS;OPHTHALMIC | 210126 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-3590 | 68071-3590-5 | 1 BOTTLE in 1 CARTON (68071-3590-5) / 2.5 mL in 1 BOTTLE |
| BIMATOPROST | bimatoprost | SOLUTION/DROPS;OPHTHALMIC | 210126 | ANDA | Gland Pharma Limited | 68083-295 | 68083-295-01 | 1 BOTTLE in 1 CARTON (68083-295-01) / 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: | Mar 22, 2019 | TE: | AT | RLD: | No | ||||
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