Details for New Drug Application (NDA): 214382
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NDA 214382 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 six 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the sevoflurane profile page.
Summary for 214382
| Tradename: | SEVOFLURANE |
| Applicant: | Shandong |
| Ingredient: | sevoflurane |
| Patents: | 0 |
Pharmacology for NDA: 214382
| Physiological Effect | General Anesthesia |
Suppliers and Packaging for NDA: 214382
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEVOFLURANE | sevoflurane | LIQUID;INHALATION | 214382 | ANDA | Lannett Company, Inc. | 0527-6123 | 0527-6123-74 | 1 BOTTLE, GLASS in 1 CARTON (0527-6123-74) / 250 mL in 1 BOTTLE, GLASS |
| SEVOFLURANE | sevoflurane | LIQUID;INHALATION | 214382 | ANDA | Shandong New Time Pharmaceutical Co., Ltd. | 42677-308 | 42677-308-01 | 1 BOTTLE, GLASS in 1 CARTON (42677-308-01) / 250 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;INHALATION | Strength | 100% | ||||
| Approval Date: | Aug 18, 2023 | TE: | AN | RLD: | No | ||||
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