Details for New Drug Application (NDA): 019452
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NDA 019452 describes DERMA-SMOOTHE/FS, which is a drug marketed by Hill Dermac and is included in one NDA. It is available from two suppliers. Additional details are available on the DERMA-SMOOTHE/FS profile page.
The generic ingredient in DERMA-SMOOTHE/FS is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
The generic ingredient in DERMA-SMOOTHE/FS is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 019452
| Tradename: | DERMA-SMOOTHE/FS |
| Applicant: | Hill Dermac |
| Ingredient: | fluocinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 019452
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 019452
Suppliers and Packaging for NDA: 019452
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DERMOTIC | fluocinolone acetonide | OIL/DROPS;OTIC | 019452 | NDA AUTHORIZED GENERIC | Seton Pharmaceuticals | 13925-507 | 13925-507-04 | 1 BOTTLE in 1 CARTON (13925-507-04) / 118.28 mL in 1 BOTTLE |
| DERMOTIC | fluocinolone acetonide | OIL/DROPS;OTIC | 019452 | NDA AUTHORIZED GENERIC | Seton Pharmaceuticals | 13925-508 | 13925-508-20 | 1 BOTTLE, DROPPER in 1 CARTON (13925-508-20) / 20 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OIL;TOPICAL | Strength | 0.01% | ||||
| Approval Date: | Feb 3, 1988 | TE: | AT | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | OIL;TOPICAL | Strength | 0.01% | ||||
| Approval Date: | Nov 9, 2005 | TE: | AT | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | OIL/DROPS;OTIC | Strength | 0.01% | ||||
| Approval Date: | Nov 9, 2005 | TE: | AT | RLD: | Yes | ||||
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