Details for New Drug Application (NDA): 040609
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NDA 040609 describes HYDROCORTISONE AND ACETIC ACID, which is a drug marketed by Bausch And Lomb, Cosette, Taro, and Wockhardt, and is included in four NDAs. It is available from two suppliers. Additional details are available on the HYDROCORTISONE AND ACETIC ACID profile page.
The generic ingredient in HYDROCORTISONE AND ACETIC ACID is acetic acid, glacial; hydrocortisone. There are thirty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the acetic acid, glacial; hydrocortisone profile page.
The generic ingredient in HYDROCORTISONE AND ACETIC ACID is acetic acid, glacial; hydrocortisone. There are thirty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the acetic acid, glacial; hydrocortisone profile page.
Summary for 040609
| Tradename: | HYDROCORTISONE AND ACETIC ACID |
| Applicant: | Cosette |
| Ingredient: | acetic acid, glacial; hydrocortisone |
| Patents: | 0 |
Pharmacology for NDA: 040609
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 040609
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE AND ACETIC ACID | acetic acid, glacial; hydrocortisone | SOLUTION/DROPS;OTIC | 040609 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0849 | 0713-0849-09 | 1 BOTTLE in 1 CARTON (0713-0849-09) / 10 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | 2%;1% | ||||
| Approval Date: | Feb 6, 2006 | TE: | AT | RLD: | No | ||||
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