Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Wockhardt Limited
650069115
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Wockhardt Limited
Wockhardt Limited
Wockhardt Limited
676257570
Products1
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
55648-632Application Number
ANDA090986Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
September 13, 2012OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 1000 ug in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT