Details for New Drug Application (NDA): 060700
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NDA 060700 describes NEO-SYNALAR, which is a drug marketed by Medimetriks Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the NEO-SYNALAR profile page.
The generic ingredient in NEO-SYNALAR is fluocinolone acetonide; neomycin sulfate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluocinolone acetonide; neomycin sulfate profile page.
The generic ingredient in NEO-SYNALAR is fluocinolone acetonide; neomycin sulfate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluocinolone acetonide; neomycin sulfate profile page.
Summary for 060700
| Tradename: | NEO-SYNALAR |
| Applicant: | Medimetriks Pharms |
| Ingredient: | fluocinolone acetonide; neomycin sulfate |
| Patents: | 0 |
Pharmacology for NDA: 060700
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 060700
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEO-SYNALAR | fluocinolone acetonide; neomycin sulfate | CREAM;TOPICAL | 060700 | ANDA | Medimetriks Pharmaceuticals | 43538-940 | 43538-940-60 | 1 TUBE in 1 CARTON (43538-940-60) / 60 g in 1 TUBE |
| NEO-SYNALAR | fluocinolone acetonide; neomycin sulfate | CREAM;TOPICAL | 060700 | ANDA | Medimetriks Pharmaceuticals | 43538-940 | 43538-940-99 | 4 TUBE in 1 CARTON (43538-940-99) / 3 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.025%;EQ 3.5MG BASE/GM | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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