Details for New Drug Application (NDA): 091449
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NDA 091449 describes LATANOPROST, which is a drug marketed by Amring Pharms, Apotex Inc, Bausch And Lomb, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Ryan Labs, Sandoz, and Somerset, and is included in nine NDAs. It is available from eight 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.
Summary for 091449
| Tradename: | LATANOPROST |
| Applicant: | Sandoz |
| Ingredient: | latanoprost |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091449
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LATANOPROST | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 091449 | ANDA | A-S Medication Solutions | 50090-7062 | 50090-7062-0 | 2.5 mL in 1 BOTTLE (50090-7062-0) |
| LATANOPROST | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 091449 | ANDA | Sandoz Inc | 61314-547 | 61314-547-01 | 2.5 mL in 1 BOTTLE (61314-547-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.005% | ||||
| Approval Date: | Mar 22, 2011 | TE: | AT | RLD: | No | ||||
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