Details for New Drug Application (NDA): 209051
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NDA 209051 describes TAFLUPROST, which is a drug marketed by Ingenus Pharms Llc, Micro Labs, and Sandoz, and is included in three NDAs. It is available from two suppliers. Additional details are available on the TAFLUPROST profile page.
The generic ingredient in TAFLUPROST is tafluprost. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tafluprost profile page.
The generic ingredient in TAFLUPROST is tafluprost. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tafluprost profile page.
Summary for 209051
| Tradename: | TAFLUPROST |
| Applicant: | Micro Labs |
| Ingredient: | tafluprost |
| Patents: | 0 |
Pharmacology for NDA: 209051
| Mechanism of Action | Prostaglandin Receptor Agonists |
| Physiological Effect | Increased Prostaglandin Activity |
Suppliers and Packaging for NDA: 209051
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAFLUPROST | tafluprost | SOLUTION/DROPS;OPHTHALMIC | 209051 | ANDA | Micro Labs Limited | 42571-264 | 42571-264-26 | 1 POUCH in 1 CARTON (42571-264-26) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL |
| TAFLUPROST | tafluprost | SOLUTION/DROPS;OPHTHALMIC | 209051 | ANDA | Micro Labs Limited | 42571-264 | 42571-264-73 | 2 POUCH in 1 CARTON (42571-264-73) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.0015% | ||||
| Approval Date: | Aug 19, 2019 | TE: | AT | RLD: | No | ||||
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