Details for New Drug Application (NDA): 072123
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The generic ingredient in DROPERIDOL is droperidol. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the droperidol profile page.
Summary for 072123
Tradename: | DROPERIDOL |
Applicant: | Am Regent |
Ingredient: | droperidol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 072123
Mechanism of Action | Dopamine D2 Antagonists |
Medical Subject Heading (MeSH) Categories for 072123
Suppliers and Packaging for NDA: 072123
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DROPERIDOL | droperidol | INJECTABLE;INJECTION | 072123 | ANDA | American Regent, Inc. | 0517-9702 | 0517-9702-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9702-25) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2.5MG/ML | ||||
Approval Date: | Oct 24, 1988 | TE: | RLD: | No |
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