Details for New Drug Application (NDA): 073037
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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 073037
Tradename: | HALOPERIDOL |
Applicant: | Pharm Assoc |
Ingredient: | haloperidol lactate |
Patents: | 0 |
Suppliers and Packaging for NDA: 073037
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | haloperidol lactate | CONCENTRATE;ORAL | 073037 | ANDA | PAI Holdings, LLC | 0121-0581 | 0121-0581-04 | 120 mL in 1 BOTTLE (0121-0581-04) |
HALOPERIDOL | haloperidol lactate | CONCENTRATE;ORAL | 073037 | ANDA | PAI Holdings, LLC | 0121-0581 | 0121-0581-05 | 10 TRAY in 1 CASE (0121-0581-05) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | EQ 2MG BASE/ML | ||||
Approval Date: | Feb 26, 1993 | TE: | AA | RLD: | No |
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