Details for New Drug Application (NDA): 088759
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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 088759
Tradename: | HYDROCORTISONE AND ACETIC ACID |
Applicant: | Taro |
Ingredient: | acetic acid, glacial; hydrocortisone |
Patents: | 0 |
Pharmacology for NDA: 088759
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 088759
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 | 088759 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-3007 | 51672-3007-1 | 1 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | 2%;1% | ||||
Approval Date: | Mar 4, 1985 | TE: | AT | RLD: | Yes |
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