Details for New Drug Application (NDA): 216918
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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 216918
Tradename: | HALOPERIDOL |
Applicant: | Mankind Pharma |
Ingredient: | haloperidol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216918
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | haloperidol | TABLET;ORAL | 216918 | ANDA | Lifestar Pharma LLC | 70756-001 | 70756-001-11 | 100 TABLET in 1 BOTTLE (70756-001-11) |
HALOPERIDOL | haloperidol | TABLET;ORAL | 216918 | ANDA | Lifestar Pharma LLC | 70756-001 | 70756-001-12 | 1000 TABLET in 1 BOTTLE (70756-001-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Apr 11, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Apr 11, 2024 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Apr 11, 2024 | TE: | AB | RLD: | No |
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