Details for New Drug Application (NDA): 013422
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NDA 013422 describes MAXIDEX, which is a drug marketed by Alcon and Harrow Eye and is included in two NDAs. It is available from one supplier. Additional details are available on the MAXIDEX profile page.
The generic ingredient in MAXIDEX is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
The generic ingredient in MAXIDEX is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
Summary for 013422
| Tradename: | MAXIDEX |
| Applicant: | Harrow Eye |
| Ingredient: | dexamethasone |
| Patents: | 0 |
Pharmacology for NDA: 013422
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 013422
Suppliers and Packaging for NDA: 013422
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MAXIDEX | dexamethasone | SUSPENSION/DROPS;OPHTHALMIC | 013422 | NDA | Harrow Eye, LLC | 82667-600 | 82667-600-05 | 1 BOTTLE, PLASTIC in 1 CARTON (82667-600-05) / 5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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