Details for New Drug Application (NDA): 074531
NDA 074531 describes FLUPHENAZINE DECANOATE, which is a drug marketed by Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, MSN, Mylan Labs Ltd, Ph Health, and Teva Parenteral, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the FLUPHENAZINE DECANOATE profile page.
The generic ingredient in FLUPHENAZINE DECANOATE is fluphenazine decanoate. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the fluphenazine decanoate profile page.
The generic ingredient in FLUPHENAZINE DECANOATE is fluphenazine decanoate. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the fluphenazine decanoate profile page.
Summary for 074531
| Tradename: | FLUPHENAZINE DECANOATE |
| Applicant: | Hikma |
| Ingredient: | fluphenazine decanoate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 074531
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUPHENAZINE DECANOATE | fluphenazine decanoate | INJECTABLE;INJECTION | 074531 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9529 | 0143-9529-01 | 1 VIAL, MULTI-DOSE in 1 BOX (0143-9529-01) / 5 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/ML | ||||
| Approval Date: | Aug 30, 1996 | TE: | AO | RLD: | No | ||||
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