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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
Effective Date
May 23, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Terbutaline(1 mg in 1 mL)

Manufacturing Establishments1

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

Medical Purchasing Solutions, LLC

Medical Purchasing Solutions. LLC

601458529

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
71872-7080
Application Number
ANDA078630
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS
Effective Date
May 23, 2023
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Code: 576PU70Y8EClass: ACTIBQuantity: 1 mg in 1 mL
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