Details for New Drug Application (NDA): 084306
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The generic ingredient in MYDRIACYL 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 084306
Tradename: | MYDRIACYL |
Applicant: | Alcon Labs Inc |
Ingredient: | tropicamide |
Patents: | 0 |
Pharmacology for NDA: 084306
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 084306
Suppliers and Packaging for NDA: 084306
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYDRIACYL | tropicamide | SOLUTION/DROPS;OPHTHALMIC | 084306 | ANDA | Alcon Laboratories, Inc. | 0065-0355 | 0065-0355-03 | 1 BOTTLE in 1 CARTON (0065-0355-03) / 3 mL in 1 BOTTLE |
MYDRIACYL | tropicamide | SOLUTION/DROPS;OPHTHALMIC | 084306 | ANDA | Alcon Laboratories, Inc. | 0998-0355 | 0998-0355-15 | 1 BOTTLE in 1 CARTON (0998-0355-15) / 15 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes |
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