Details for New Drug Application (NDA): 208197
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NDA 208197 describes DROPERIDOL, which is a drug marketed by Abraxis Pharm, Am Regent, Astrazeneca, Hikma, Hospira, Igi Labs Inc, Luitpold, Smith And Nephew, Solopak, and Watson Labs, and is included in eighteen NDAs. It is available from two suppliers. Additional details are available on the DROPERIDOL profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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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