Details for New Drug Application (NDA): 215509
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NDA 215509 describes FLUPHENAZINE DECANOATE, which is a drug marketed by Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Mylan Labs Ltd, and Teva Parenteral, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the FLUPHENAZINE DECANOATE profile page.
The generic ingredient in FLUPHENAZINE DECANOATE is fluphenazine decanoate. There are nineteen drug master file entries for this compound. Eight 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 are nineteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fluphenazine decanoate profile page.
Summary for 215509
| Tradename: | FLUPHENAZINE DECANOATE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | fluphenazine decanoate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215509
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUPHENAZINE DECANOATE | fluphenazine decanoate | INJECTABLE;INJECTION | 215509 | ANDA | Sagent Pharmaceuticals | 25021-838 | 25021-838-05 | 1 VIAL in 1 CARTON (25021-838-05) / 5 mL in 1 VIAL |
| FLUPHENAZINE DECANOATE | fluphenazine decanoate | INJECTABLE;INJECTION | 215509 | ANDA | Gland Pharma Limited | 68083-476 | 68083-476-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-476-01) / 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: | Mar 30, 2023 | TE: | AO | RLD: | No | ||||
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