Details for New Drug Application (NDA): 012770
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NDA 012770 describes VOSOL HC, which is a drug marketed by Saptalis Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the VOSOL HC profile page.
The generic ingredient in VOSOL HC 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 HC 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 012770
| Tradename: | VOSOL HC |
| Applicant: | Saptalis Pharms |
| Ingredient: | acetic acid, glacial; hydrocortisone |
| Patents: | 0 |
Pharmacology for NDA: 012770
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 012770
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VOSOL HC | acetic acid, glacial; hydrocortisone | SOLUTION/DROPS;OTIC | 012770 | NDA | Saptalis Pharmaceuticals, LLC | 71656-064 | 71656-064-10 | 1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | 2%;1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes | ||||
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