Details for New Drug Application (NDA): 211061
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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 211061
Tradename: | HALOPERIDOL |
Applicant: | Upsher Smith Labs |
Ingredient: | haloperidol |
Patents: | 0 |
Suppliers and Packaging for NDA: 211061
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | haloperidol | TABLET;ORAL | 211061 | ANDA | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8355 | 0615-8355-39 | 30 TABLET in 1 BLISTER PACK (0615-8355-39) |
HALOPERIDOL | haloperidol | TABLET;ORAL | 211061 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1510 | 0832-1510-11 | 100 TABLET in 1 BOTTLE (0832-1510-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Jan 8, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Jan 8, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Jan 8, 2020 | TE: | AB | RLD: | No |
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