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FDA Approval

Terbutaline Sulfate

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

FDA Approval Summary

Company
Henry Schein, Inc.
DUNS: 012430880
Effective Date
May 22, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Terbutaline(1 mg in 1 mL)

Products1

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

Terbutaline Sulfate

Product Details

NDC Product Code
0404-9962
Application Number
ANDA076887
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS
Effective Date
January 12, 2022
Code: 576PU70Y8EClass: ACTIBQuantity: 1 mg in 1 mL
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