Details for New Drug Application (NDA): 012787
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NDA 012787 describes SYNALAR, which is a drug marketed by Medimetriks Pharms and is included in four NDAs. It is available from two suppliers. 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 012787
| Tradename: | SYNALAR |
| Applicant: | Medimetriks Pharms |
| Ingredient: | fluocinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 012787
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 012787
Suppliers and Packaging for NDA: 012787
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYNALAR | fluocinolone acetonide | CREAM;TOPICAL | 012787 | NDA | Medimetriks Pharmaceuticals, Inc. | 43538-900 | 43538-900-12 | 1 TUBE in 1 CARTON (43538-900-12) / 120 g in 1 TUBE |
| SYNALAR | fluocinolone acetonide | CREAM;TOPICAL | 012787 | NDA AUTHORIZED GENERIC | ANI Pharmaceuticals, Inc. | 62559-288 | 62559-288-15 | 1 TUBE in 1 CARTON (62559-288-15) / 15 g in 1 TUBE |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.025% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes | ||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.01% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes | ||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.025% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes | ||||
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