Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
USV North America Inc.
964227149
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.
USV North America Inc.
650434348
Products2
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
76135-005Application Number
ANDA203765Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
December 26, 2011ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 200 ug in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
Octreotide Acetate
Product Details
NDC Product Code
76135-006Application Number
ANDA203765Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
December 26, 2011OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 1000 ug in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL