Details for New Drug Application (NDA): 216649
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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 216649
Tradename: | FLUPHENAZINE HYDROCHLORIDE |
Applicant: | Apotex |
Ingredient: | fluphenazine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216649
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 216649 | ANDA | Apotex Corp. | 60505-4768 | 60505-4768-1 | 100 TABLET in 1 BOTTLE (60505-4768-1) |
FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 216649 | ANDA | Apotex Corp. | 60505-4769 | 60505-4769-1 | 100 TABLET in 1 BOTTLE (60505-4769-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Jul 15, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Jul 15, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jul 15, 2022 | TE: | AB | RLD: | No |
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