Details for New Drug Application (NDA): 015296
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NDA 015296 describes SYNALAR, which is a drug marketed by Medimetriks Pharms and is included in four NDAs. It is available from one supplier. Additional details are available on the SYNALAR profile page.
The generic ingredient in SYNALAR 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 SYNALAR 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 015296
| Tradename: | SYNALAR |
| Applicant: | Medimetriks Pharms |
| Ingredient: | fluocinolone acetonide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 015296
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 015296
Suppliers and Packaging for NDA: 015296
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYNALAR | fluocinolone acetonide | SOLUTION;TOPICAL | 015296 | NDA | Medimetriks Pharmaceuticals, Inc. | 43538-920 | 43538-920-60 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (43538-920-60) / 60 mL in 1 BOTTLE, WITH APPLICATOR |
| SYNALAR | fluocinolone acetonide | SOLUTION;TOPICAL | 015296 | NDA | Medimetriks Pharmaceuticals, Inc. | 43538-921 | 43538-921-60 | 1 KIT in 1 CARTON (43538-921-60) * 60 mL in 1 BOTTLE, WITH APPLICATOR * 454 g in 1 BOTTLE, PUMP |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.01% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes | ||||
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