Details for New Drug Application (NDA): 213647
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NDA 213647 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, Breckenridge, 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 twenty-eight 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the fluphenazine hydrochloride profile page.
Summary for 213647
| Tradename: | FLUPHENAZINE HYDROCHLORIDE |
| Applicant: | Amneal |
| Ingredient: | fluphenazine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213647
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 213647 | ANDA | Coupler LLC | 67046-1009 | 67046-1009-3 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1009-3) |
| FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 213647 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1678 | 69238-1678-1 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1678-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Jul 9, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jul 9, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jul 9, 2020 | TE: | AB | RLD: | No | ||||
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