Details for New Drug Application (NDA): 210736
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NDA 210736 describes FLAC, which is a drug marketed by Anda Repository and is included in one NDA. It is available from one supplier. Additional details are available on the FLAC profile page.
The generic ingredient in FLAC is fluocinolone acetonide. There are twelve drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
The generic ingredient in FLAC is fluocinolone acetonide. There are twelve drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 210736
| Tradename: | FLAC |
| Applicant: | Anda Repository |
| Ingredient: | fluocinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 210736
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210736
Suppliers and Packaging for NDA: 210736
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLAC | fluocinolone acetonide | OIL/DROPS;OTIC | 210736 | ANDA | Patrin Pharma, Inc. | 39328-079 | 39328-079-20 | 1 BOTTLE, DROPPER in 1 CARTON (39328-079-20) / 20 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OIL/DROPS;OTIC | Strength | 0.01% | ||||
| Approval Date: | Apr 11, 2018 | TE: | AT | RLD: | No | ||||
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