Details for New Drug Application (NDA): 208197
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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 208197
Tradename: | DROPERIDOL |
Applicant: | Hikma |
Ingredient: | droperidol |
Patents: | 0 |
Pharmacology for NDA: 208197
Mechanism of Action | Dopamine D2 Antagonists |
Medical Subject Heading (MeSH) Categories for 208197
Suppliers and Packaging for NDA: 208197
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DROPERIDOL | droperidol | INJECTABLE;INJECTION | 208197 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9514 | 0143-9514-25 | 25 VIAL in 1 CARTON (0143-9514-25) / 2 mL in 1 VIAL (0143-9514-01) |
DROPERIDOL | droperidol | INJECTABLE;INJECTION | 208197 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9515 | 0143-9515-25 | 25 VIAL in 1 CARTON (0143-9515-25) / 1 mL in 1 VIAL (0143-9515-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 2.5MG/ML | ||||
Approval Date: | Dec 14, 2017 | TE: | RLD: | No |
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