Details for New Drug Application (NDA): 214552
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NDA 214552 describes FLUPHENAZINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Pharm Assoc, Fresenius Kabi Usa, Ajanta Pharma Ltd, Alembic, Amneal, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Glenmark Pharms Ltd, Lannett Co Inc, MSN, Novitium Pharma, Prasco, Rising, Sandoz, Taro, Torrent, Twi Pharms, Upsher Smith Labs, Watson Labs, and Zydus Lifesciences, and is included in twenty-nine NDAs. It is available from thirty-one 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. Thirty-one 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. Thirty-one suppliers are listed for this compound. Additional details are available on the fluphenazine hydrochloride profile page.
Summary for 214552
| Tradename: | FLUPHENAZINE HYDROCHLORIDE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | fluphenazine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214552
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 214552 | ANDA | Northstar Rx LLC | 16714-674 | 16714-674-02 | 500 TABLET, FILM COATED in 1 BOTTLE (16714-674-02) |
| FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 214552 | ANDA | Northstar Rx LLC | 16714-675 | 16714-675-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-675-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | May 27, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | May 27, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 27, 2021 | TE: | AB | RLD: | No | ||||
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