Details for New Drug Application (NDA): 075225
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NDA 075225 describes ISOFLURANE, which is a drug marketed by Halocarbon Prods, Hospira, Piramal Critical, Piramal Pharma, and Watson Labs Inc, and is included in five NDAs. It is available from three suppliers. Additional details are available on the ISOFLURANE profile page.
The generic ingredient in ISOFLURANE is isoflurane. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the isoflurane profile page.
The generic ingredient in ISOFLURANE is isoflurane. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the isoflurane profile page.
Summary for 075225
| Tradename: | ISOFLURANE |
| Applicant: | Halocarbon Prods |
| Ingredient: | isoflurane |
| Patents: | 0 |
Pharmacology for NDA: 075225
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 075225
Suppliers and Packaging for NDA: 075225
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISOFLURANE | isoflurane | LIQUID;INHALATION | 075225 | ANDA | Halocarbon Life Sciences, LLC | 12164-012 | 12164-012-10 | 100 mL in 1 BOTTLE, GLASS (12164-012-10) |
| ISOFLURANE | isoflurane | LIQUID;INHALATION | 075225 | ANDA | Halocarbon Life Sciences, LLC | 12164-012 | 12164-012-25 | 250 mL in 1 BOTTLE, GLASS (12164-012-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;INHALATION | Strength | 99.9% | ||||
| Approval Date: | Oct 20, 1999 | TE: | AN | RLD: | No | ||||
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