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FDA Approval

Desflurane

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Sandoz Inc.
DUNS: 005387188
Effective Date
November 8, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Desflurane(240 mL in 240 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Shanghai Hengrui Pharmaceutical Co., Ltd.

Sandoz Inc.

Shanghai Hengrui Pharmaceutical Co., Ltd.

527903636

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Desflurane

Product Details

NDC Product Code
0781-6172
Application Number
ANDA208234
Marketing Category
ANDA (C73584)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
November 8, 2022
Code: CRS35BZ94QClass: ACTIBQuantity: 240 mL in 240 mL
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