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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
USV North America Inc.
DUNS: 964227149
Effective Date
January 7, 2019
Labeling Type
Human Prescription Drug Label
Octreotide(50 ug in 1 mL)

Manufacturing Establishments1

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

USV Private Limited

USV North America Inc.

650434348

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
76135-009
Application Number
ANDA204669
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, SUBCUTANEOUS
Effective Date
February 7, 2013
Code: 75R0U2568IClass: ACTIMQuantity: 50 ug in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

OCTREOTIDE ACETATE

Product Details

NDC Product Code
76135-011
Application Number
ANDA204669
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, SUBCUTANEOUS
Effective Date
February 7, 2013
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 75R0U2568IClass: ACTIMQuantity: 500 ug in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL

OCTREOTIDE ACETATE

Product Details

NDC Product Code
76135-010
Application Number
ANDA204669
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, SUBCUTANEOUS
Effective Date
February 7, 2013
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 75R0U2568IClass: ACTIMQuantity: 100 ug in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL
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