Details for New Drug Application (NDA): 218257
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NDA 218257 describes LATANOPROST, which is a drug marketed by Amring Pharms, Apotex Inc, Bausch And Lomb, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland, Ryan Labs, Sandoz, and Somerset, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the LATANOPROST profile page.
The generic ingredient in LATANOPROST is latanoprost. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.
The generic ingredient in LATANOPROST is latanoprost. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.
Summary for 218257
| Tradename: | LATANOPROST |
| Applicant: | Gland |
| Ingredient: | latanoprost |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218257
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LATANOPROST | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 218257 | ANDA | Gland Pharma Limited | 68083-609 | 68083-609-01 | 1 BOTTLE in 1 CARTON (68083-609-01) / 2.5 mL in 1 BOTTLE |
| LATANOPROST | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 218257 | ANDA | GLENMARK PHARMACEUTICALS INC | 68462-944 | 68462-944-03 | 1 BOTTLE in 1 CARTON (68462-944-03) / 2.5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.005% | ||||
| Approval Date: | Nov 26, 2024 | TE: | AT | RLD: | No | ||||
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