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FDA Approval

Teriparatide

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

FDA Approval Summary

Company
Effective Date
November 1, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Teriparatide(250 ug in 1 mL)

Products1

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

Teriparatide

Product Details

NDC Product Code
0093-1106
Application Number
ANDA208569
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS
Effective Date
November 1, 2021
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
Code: 9959P4V12NClass: ACTIMQuantity: 250 ug in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
METACRESOLInactive
Code: GGO4Y809LOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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