Details for New Drug Application (NDA): 218789
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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 218789
Tradename: | HALOPERIDOL |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | haloperidol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 218789
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | haloperidol | TABLET;ORAL | 218789 | ANDA | Aurobindo Pharma Limited | 59651-789 | 59651-789-01 | 100 TABLET in 1 BOTTLE (59651-789-01) |
HALOPERIDOL | haloperidol | TABLET;ORAL | 218789 | ANDA | Aurobindo Pharma Limited | 59651-789 | 59651-789-99 | 1000 TABLET in 1 BOTTLE (59651-789-99) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Apr 19, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Apr 19, 2024 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Apr 19, 2024 | TE: | AB | RLD: | No |
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