Details for New Drug Application (NDA): 202442
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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 202442
Tradename: | LATANOPROST |
Applicant: | Fdc Ltd |
Ingredient: | latanoprost |
Patents: | 0 |
Suppliers and Packaging for NDA: 202442
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LATANOPROST | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 202442 | ANDA | Rising Pharma Holdings, Inc. | 64980-516 | 64980-516-25 | 1 BOTTLE, DROPPER in 1 CARTON (64980-516-25) / 2.5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.005% | ||||
Approval Date: | Apr 22, 2016 | TE: | AT | RLD: | No |
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