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FDA Approval

Octreotide Acetate

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

FDA Approval Summary

Company
Effective Date
November 9, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Octreotide(100 ug in 1 mL)

Products3

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

Octreotide Acetate

Product Details

NDC Product Code
67457-245
Application Number
ANDA079198
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS, INTRAVENOUS
Effective Date
November 9, 2022
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: 75R0U2568IClass: ACTIMQuantity: 100 ug in 1 mL
LACTIC ACID, L-Inactive
Code: F9S9FFU82NClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT

Octreotide Acetate

Product Details

NDC Product Code
67457-239
Application Number
ANDA079198
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS, INTRAVENOUS
Effective Date
November 9, 2022
LACTIC ACID, L-Inactive
Code: F9S9FFU82NClass: IACT
Code: 75R0U2568IClass: ACTIMQuantity: 50 ug in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT

Octreotide Acetate

Product Details

NDC Product Code
67457-246
Application Number
ANDA079198
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS, INTRAVENOUS
Effective Date
November 9, 2022
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: 75R0U2568IClass: ACTIMQuantity: 500 ug in 1 mL
LACTIC ACID, L-Inactive
Code: F9S9FFU82NClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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