Details for New Drug Application (NDA): 209101
NDA 209101 describes HALOPERIDOL DECANOATE, which is a drug marketed by Caplin, Fresenius Kabi Usa, Gland, Hikma, Hospira, Mankind Pharma, Meitheal, Mylan Labs Ltd, Sandoz, Somerset Theraps Llc, Teva Pharms Usa, and Zydus Pharms, and is included in thirteen NDAs. It is available from fifteen suppliers. Additional details are available on the HALOPERIDOL DECANOATE profile page.
The generic ingredient in HALOPERIDOL DECANOATE is haloperidol decanoate. There is one drug master file entry for this compound. Sixteen 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 is one drug master file entry for this compound. Sixteen 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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