Details for New Drug Application (NDA): 012179
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NDA 012179 describes VOSOL, which is a drug marketed by Hikma and Saptalis Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the VOSOL profile page.
The generic ingredient in VOSOL 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 VOSOL 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 012179
| Tradename: | VOSOL |
| Applicant: | Hikma |
| Ingredient: | acetic acid, glacial |
| Patents: | 0 |
Suppliers and Packaging for NDA: 012179
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VOSOL | acetic acid, glacial | SOLUTION/DROPS;OTIC | 012179 | NDA | NuCare Pharmaceuticals,Inc. | 68071-1739 | 68071-1739-5 | 15 mL in 1 BOTTLE (68071-1739-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OTIC | Strength | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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