Details for New Drug Application (NDA): 216730
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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 216730
Tradename: | HALOPERIDOL DECANOATE |
Applicant: | Mankind Pharma |
Ingredient: | haloperidol decanoate |
Patents: | 0 |
Suppliers and Packaging for NDA: 216730
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 216730 | ANDA | Lifestar Pharma LLC | 70756-615 | 70756-615-10 | 10 VIAL in 1 CARTON (70756-615-10) / 1 mL in 1 VIAL |
HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 216730 | ANDA | Lifestar Pharma LLC | 70756-615 | 70756-615-33 | 3 VIAL in 1 CARTON (70756-615-33) / 1 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML | ||||
Approval Date: | May 23, 2023 | TE: | AO | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/ML | ||||
Approval Date: | May 23, 2023 | TE: | AO | RLD: | No |
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