Details for New Drug Application (NDA): 209101
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NDA 209101 describes HALOPERIDOL DECANOATE, which is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Mankind Pharma, Meitheal, Mylan Labs Ltd, Sandoz, Somerset Theraps Llc, Teva Pharms Usa, and Zydus Pharms, and is included in twelve NDAs. It is available from thirteen suppliers. Additional details are available on the HALOPERIDOL DECANOATE profile page.
The generic ingredient in HALOPERIDOL DECANOATE is haloperidol decanoate. There are twenty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
The generic ingredient in HALOPERIDOL DECANOATE is haloperidol decanoate. There are twenty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 209101
| Tradename: | HALOPERIDOL DECANOATE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | haloperidol decanoate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209101
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 209101 | ANDA | BluePoint Laboratories | 68001-578 | 68001-578-48 | 3 AMPULE in 1 CARTON (68001-578-48) / 1 mL in 1 AMPULE (68001-578-59) |
| HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 209101 | ANDA | BluePoint Laboratories | 68001-579 | 68001-579-48 | 5 AMPULE in 1 CARTON (68001-579-48) / 1 mL in 1 AMPULE (68001-579-59) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML | ||||
| Approval Date: | Jul 3, 2018 | TE: | AO | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/ML | ||||
| Approval Date: | Jul 3, 2018 | TE: | AO | RLD: | No | ||||
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