Details for New Drug Application (NDA): 214552
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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 214552
Tradename: | FLUPHENAZINE HYDROCHLORIDE |
Applicant: | Zydus |
Ingredient: | fluphenazine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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 | 16714-672 | 16714-672-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-672-01) |
FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 214552 | ANDA | Northstar Rx LLC | 16714-673 | 16714-673-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-673-01) |
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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