Details for New Drug Application (NDA): 076774
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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 076774
Tradename: | HALOPERIDOL |
Applicant: | Gland Pharma Ltd |
Ingredient: | haloperidol lactate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076774
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | haloperidol lactate | INJECTABLE;INJECTION | 076774 | ANDA | Gland Pharma Limited | 68083-117 | 68083-117-01 | 10 SYRINGE in 1 BOX (68083-117-01) / 1 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
Approval Date: | Aug 25, 2004 | TE: | AP | RLD: | No |
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