Details for New Drug Application (NDA): 078650
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NDA 078650 describes SEVOFLURANE, which is a drug marketed by Baxter Hlthcare, Halocarbon Prods, Shandong, and Shanghai Hengrui, and is included in four NDAs. It is available from eight suppliers. Additional details are available on the SEVOFLURANE profile page.
The generic ingredient in SEVOFLURANE is sevoflurane. There are five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sevoflurane profile page.
The generic ingredient in SEVOFLURANE is sevoflurane. There are five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sevoflurane profile page.
Summary for 078650
| Tradename: | SEVOFLURANE |
| Applicant: | Halocarbon Prods |
| Ingredient: | sevoflurane |
| Patents: | 0 |
Pharmacology for NDA: 078650
| Physiological Effect | General Anesthesia |
Suppliers and Packaging for NDA: 078650
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEVOFLURANE | sevoflurane | LIQUID;INHALATION | 078650 | ANDA | Halocarbon Life Sciences, LLC | 12164-005 | 12164-005-25 | 250 mL in 1 BOTTLE (12164-005-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;INHALATION | Strength | 100% | ||||
| Approval Date: | Nov 19, 2007 | TE: | AN | RLD: | No | ||||
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