Details for New Drug Application (NDA): 207524
✉ Email this page to a colleague
NDA 207524 describes TROPICAMIDE, which is a drug marketed by Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Miza Pharms Usa, Somerset Theraps Llc, and Watson Labs, and is included in eight NDAs. It is available from two suppliers. Additional details are available on the TROPICAMIDE profile page.
The generic ingredient in TROPICAMIDE is tropicamide. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tropicamide profile page.
The generic ingredient in TROPICAMIDE is tropicamide. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tropicamide profile page.
Summary for 207524
| Tradename: | TROPICAMIDE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | tropicamide |
| Patents: | 0 |
Pharmacology for NDA: 207524
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 207524
Suppliers and Packaging for NDA: 207524
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TROPICAMIDE | tropicamide | SOLUTION/DROPS;OPHTHALMIC | 207524 | ANDA | Somerset Therapeutics, LLC | 70069-121 | 70069-121-01 | 1 BOTTLE in 1 CARTON (70069-121-01) / 15 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Dec 12, 2019 | TE: | AT | RLD: | No | ||||
Complete Access Available with Subscription
