Details for New Drug Application (NDA): 213784
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NDA 213784 describes FLUPHENAZINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Pharm Assoc, Fresenius Kabi Usa, Ajanta Pharma Ltd, Amneal, Apotex, Aurobindo Pharma Ltd, Dr Reddys, Glenmark Pharms Ltd, Lannett Co Inc, MSN, Novitium Pharma, Prasco, Sandoz, Taro, Torrent, Twi Pharms, Upsher Smith Labs, Watson Labs, Zameer Pharms, and Zydus, and is included in twenty-seven NDAs. It is available from twenty-seven suppliers. Additional details are available on the FLUPHENAZINE HYDROCHLORIDE profile page.
The generic ingredient in FLUPHENAZINE HYDROCHLORIDE is fluphenazine hydrochloride. There are nineteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the fluphenazine hydrochloride profile page.
The generic ingredient in FLUPHENAZINE HYDROCHLORIDE is fluphenazine hydrochloride. There are nineteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the fluphenazine hydrochloride profile page.
Summary for 213784
| Tradename: | FLUPHENAZINE HYDROCHLORIDE |
| Applicant: | Upsher Smith Labs |
| Ingredient: | fluphenazine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213784
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 213784 | ANDA | Upsher-Smith Laboratories,LLC | 0832-6003 | 0832-6003-11 | 100 TABLET, FILM COATED in 1 BOTTLE (0832-6003-11) |
| FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 213784 | ANDA | Upsher-Smith Laboratories,LLC | 0832-6004 | 0832-6004-11 | 100 TABLET, FILM COATED in 1 BOTTLE (0832-6004-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Oct 24, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Oct 24, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Oct 24, 2022 | TE: | AB | RLD: | No | ||||
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