Details for New Drug Application (NDA): 075858
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The generic ingredient in HALOPERIDOL 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 075858
Tradename: | HALOPERIDOL |
Applicant: | Hikma |
Ingredient: | haloperidol lactate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 075858
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | haloperidol lactate | INJECTABLE;INJECTION | 075858 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9319 | 0143-9319-25 | 25 VIAL in 1 BOX (0143-9319-25) / 1 mL in 1 VIAL |
HALOPERIDOL | haloperidol lactate | INJECTABLE;INJECTION | 075858 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9501 | 0143-9501-25 | 25 VIAL in 1 BOX (0143-9501-25) / 1 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
Approval Date: | Jun 18, 2001 | TE: | AP | RLD: | No |
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