Details for New Drug Application (NDA): 062521
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NDA 062521 describes OTOCORT, which is a drug marketed by Watson Labs and Actavis Labs Fl Inc and is included in two NDAs. Additional details are available on the OTOCORT profile page.
The generic ingredient in OTOCORT is hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are sixty-seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
The generic ingredient in OTOCORT is hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are sixty-seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 062521
| Tradename: | OTOCORT |
| Applicant: | Actavis Labs Fl Inc |
| Ingredient: | hydrocortisone; neomycin sulfate; polymyxin b sulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION/DROPS;OTIC | Strength | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | ||||
| Approval Date: | Jul 11, 1985 | TE: | RLD: | No | |||||
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