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FDA Approval

Amytal Sodium

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

FDA Approval Summary

Company
Bausch Health US, LLC
DUNS: 831922468
Effective Date
July 1, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Amobarbital(0.5 g in 5 mL)

Manufacturing Establishments1

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

Alcami Carolinas Corporation

Bausch Health US, LLC

832394733

Products1

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

Amytal Sodium

Product Details

NDC Product Code
0187-4303
Route of Administration
INTRAMUSCULAR, INTRAVENOUS
Effective Date
July 1, 2020
Code: G0313KNC7DClass: ACTIBQuantity: 0.5 g in 5 mL
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