Details for New Drug Application (NDA): 071209
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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 071209
Tradename: | HALOPERIDOL |
Applicant: | Chartwell Rx |
Ingredient: | haloperidol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 071209
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | haloperidol | TABLET;ORAL | 071209 | ANDA | Proficient Rx LP | 63187-842 | 63187-842-03 | 3 TABLET in 1 BOTTLE (63187-842-03) |
HALOPERIDOL | haloperidol | TABLET;ORAL | 071209 | ANDA | Proficient Rx LP | 63187-842 | 63187-842-30 | 30 TABLET in 1 BOTTLE (63187-842-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 17, 1986 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Nov 17, 1986 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Nov 17, 1986 | TE: | AB | RLD: | No |
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