Details for New Drug Application (NDA): 060613
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NDA 060613 describes CASPORYN HC, which is a drug marketed by Casper Pharma Llc and is included in one NDA. It is available from four suppliers. Additional details are available on the CASPORYN HC profile page.
The generic ingredient in CASPORYN HC 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 CASPORYN HC 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 060613
| Tradename: | CASPORYN HC |
| Applicant: | Casper Pharma Llc |
| Ingredient: | hydrocortisone; neomycin sulfate; polymyxin b sulfate |
| Patents: | 0 |
Pharmacology for NDA: 060613
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 060613
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CASPORYN HC | hydrocortisone; neomycin sulfate; polymyxin b sulfate | SUSPENSION/DROPS;OTIC | 060613 | NDA AUTHORIZED GENERIC | A-S Medication Solutions | 50090-6336 | 50090-6336-0 | 1 BOTTLE in 1 CARTON (50090-6336-0) / 10 mL in 1 BOTTLE |
| CASPORYN HC | hydrocortisone; neomycin sulfate; polymyxin b sulfate | SUSPENSION/DROPS;OTIC | 060613 | NDA AUTHORIZED GENERIC | Rising Pharma Holdings, Inc. | 64980-448 | 64980-448-01 | 1 BOTTLE in 1 CARTON (64980-448-01) / 10 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OTIC | Strength | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes | ||||
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