Details for New Drug Application (NDA): 084305
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NDA 084305 describes MYDRIACYL, which is a drug marketed by Alcon, Alcon Labs Inc, and Sandoz, and is included in three NDAs. It is available from two suppliers. Additional details are available on the MYDRIACYL profile page.
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.
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 084305
| Tradename: | MYDRIACYL |
| Applicant: | Sandoz |
| Ingredient: | tropicamide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 084305
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 084305
Suppliers and Packaging for NDA: 084305
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYDRIACYL | tropicamide | SOLUTION/DROPS;OPHTHALMIC | 084305 | ANDA | Sandoz Inc | 61314-354 | 61314-354-01 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-354-01) / 15 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes | ||||
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