Details for New Drug Application (NDA): 050356
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NDA 050356 describes COLY-MYCIN S, which is a drug marketed by Endo Operations and Parke Davis and is included in two NDAs. It is available from one supplier. Additional details are available on the COLY-MYCIN S profile page.
The generic ingredient in COLY-MYCIN S is colistin sulfate. There are four drug master file entries for this compound. Additional details are available on the colistin sulfate profile page.
The generic ingredient in COLY-MYCIN S is colistin sulfate. There are four drug master file entries for this compound. Additional details are available on the colistin sulfate profile page.
Summary for 050356
| Tradename: | COLY-MYCIN S |
| Applicant: | Endo Operations |
| Ingredient: | colistin sulfate; hydrocortisone acetate; neomycin sulfate; thonzonium bromide |
| Patents: | 0 |
Pharmacology for NDA: 050356
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 050356
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLY-MYCIN S | colistin sulfate; hydrocortisone acetate; neomycin sulfate; thonzonium bromide | SUSPENSION/DROPS;OTIC | 050356 | NDA | Endo USA, Inc. | 63481-529 | 63481-529-10 | 10 mL in 1 BOTTLE, DROPPER (63481-529-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OTIC | Strength | EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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