Details for New Drug Application (NDA): 211180
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NDA 211180 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 fourteen 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. 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 are twenty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 211180
| Tradename: | HALOPERIDOL DECANOATE |
| Applicant: | Zydus Pharms |
| Ingredient: | haloperidol decanoate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211180
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 211180 | ANDA | BluePoint Laboratories | 68001-657 | 68001-657-51 | 3 VIAL, SINGLE-DOSE in 1 CARTON (68001-657-51) / 1 mL in 1 VIAL, SINGLE-DOSE (68001-657-41) |
| HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 211180 | ANDA | BluePoint Laboratories | 68001-657 | 68001-657-56 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68001-657-56) / 1 mL in 1 VIAL, SINGLE-DOSE (68001-657-41) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML | ||||
| Approval Date: | Oct 22, 2019 | TE: | AO | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/ML | ||||
| Approval Date: | Oct 22, 2019 | TE: | AO | RLD: | No | ||||
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