Details for New Drug Application (NDA): 214507
✉ Email this page to a colleague
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 214507
Tradename: | HALOPERIDOL DECANOATE |
Applicant: | Meitheal |
Ingredient: | haloperidol decanoate |
Patents: | 0 |
Suppliers and Packaging for NDA: 214507
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 214507 | ANDA | REMEDYREPACK INC. | 70518-3743 | 70518-3743-0 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70518-3743-0) / 1 mL in 1 VIAL, SINGLE-DOSE (70518-3743-1) |
HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 214507 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-502 | 71288-502-02 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-502-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-502-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML | ||||
Approval Date: | Jul 26, 2021 | 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 26, 2021 | TE: | AO | RLD: | No |
Complete Access Available with Subscription