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Details for New Drug Application (NDA): 078347
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The generic ingredient in HALOPERIDOL is haloperidol decanoate. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 078347
Tradename: | HALOPERIDOL |
Applicant: | Mylan Labs Ltd |
Ingredient: | haloperidol lactate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078347
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | haloperidol lactate | INJECTABLE;INJECTION | 078347 | ANDA | General Injectables and Vaccines, Inc. | 52584-426 | 52584-426-00 | 1 VIAL in 1 BAG (52584-426-00) > 1 mL in 1 VIAL |
HALOPERIDOL | haloperidol lactate | INJECTABLE;INJECTION | 078347 | ANDA | Cardinal Health | 55154-7076 | 55154-7076-5 | 5 VIAL in 1 BAG (55154-7076-5) > 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: | Sep 14, 2009 | TE: | AP | RLD: | No |
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