Details for New Drug Application (NDA): 071132
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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 071132
Tradename: | HALOPERIDOL |
Applicant: | Sciegen Pharms Inc |
Ingredient: | haloperidol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 071132
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | haloperidol | TABLET;ORAL | 071132 | ANDA | Burel Pharmaceuticals, LLC | 35573-442 | 35573-442-02 | 100 TABLET in 1 BOTTLE (35573-442-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | May 12, 1987 | TE: | AB | RLD: | No |
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