Octreotide Injectable Solution

Brand(s)
Sandostatin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2013-07-29)
Oldest Current Product
1988-10-21
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\OCTREOTIDE
FDAOB
INJECTION\INJECTION\OCTREOTIDE ACETATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\OCTREOTIDE ACETATE
INTRAVENOUS\INJECTION, SOLUTION\OCTREOTIDE ACETATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\OCTREOTIDE
INTRAVENOUS\INJECTION, SOLUTION\OCTREOTIDE

product(s) by strength(s)

octreotide 0.2 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813165NDASandoz Inc1988-10-21OCTREOTIDE ACETATEINTRAVENOUSINJECTION, SOLUTIONNDA01966776146a72-05fe-4804-a9c2-df573c97d9cb

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007033333ANDATeva Parenteral Medicines, Inc2005-11-23OCTREOTIDE ACETATEINTRAVENOUSINJECTION, SOLUTIONANDA07595920917b50-512f-45c9-a446-1e8a509f3687
2250210454ANDASagent Pharmaceuticals2013-12-15OCTREOTIDE ACETATEINTRAMUSCULARINJECTION, SOLUTIONANDA091041c228ff95-7052-465f-9344-22915b2ce4c8
3627560350ANDASun Pharmaceutical Industries Limited2007-08-14OCTREOTIDE ACETATEINTRAVENOUSINJECTION, SOLUTIONANDA0773733cf0c341-60a5-466b-b907-5826e8e0874a
4633230378ANDAApp Pharmaceuticals, Llc2006-03-14OCTREOTIDE ACETATEINTRAVENOUSINJECTION, SOLUTIONANDA077450f278f0d8-4062-420a-97c3-3a8b88253a08

octreotide 1 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813164NDASandoz Inc1988-10-21OCTREOTIDE ACETATEINTRAVENOUSINJECTION, SOLUTIONNDA01966776146a72-05fe-4804-a9c2-df573c97d9cb

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007033343ANDATeva Parenteral Medicines, Inc2005-11-23OCTREOTIDE ACETATEINTRAVENOUSINJECTION, SOLUTIONANDA07595920917b50-512f-45c9-a446-1e8a509f3687
2250210455ANDASagent Pharmaceuticals2013-12-15OCTREOTIDE ACETATEINTRAMUSCULARINJECTION, SOLUTIONANDA091041c228ff95-7052-465f-9344-22915b2ce4c8
3627560352ANDASun Pharmaceutical Industries Limited2007-08-14OCTREOTIDE ACETATEINTRAVENOUSINJECTION, SOLUTIONANDA0773733cf0c341-60a5-466b-b907-5826e8e0874a
4633230379ANDAApp Pharmaceuticals, Llc2006-03-14OCTREOTIDE ACETATEINTRAVENOUSINJECTION, SOLUTIONANDA077450f278f0d8-4062-420a-97c3-3a8b88253a08

application(s)

#idtitleapplicantapprovedpatentapproved drugin other drug docs
1ANDA075957OCTREOTIDE ACETATETEVA PHARMACEUTICALS USA2005-10-03ANDA075957_001, ANDA075957_002, ANDA075957_003Octreotide Prefilled Syringe
Octreotide Injection
2ANDA075959OCTREOTIDE ACETATETEVA PHARMACEUTICALS USA2005-11-21ANDA075959_001, ANDA075959_002Octreotide Prefilled Syringe
Octreotide Injection
3ANDA076313OCTREOTIDE ACETATE (PRESERVATIVE FREE)EUROHEALTH INTERNATIONAL SARL2005-03-28ANDA076313_001, ANDA076313_002, ANDA076313_003Octreotide Prefilled Syringe
Octreotide Injection
4ANDA076330OCTREOTIDE ACETATEEUROHEALTH INTERNATIONAL SARL2005-04-08ANDA076330_001, ANDA076330_002Octreotide Prefilled Syringe
Octreotide Injection
5ANDA077329OCTREOTIDE ACETATESUN PHARMACEUTICAL INDUSTRIES LTD2008-03-04ANDA077329_001, ANDA077329_002, ANDA077329_003Octreotide Prefilled Syringe
Octreotide Injection
6ANDA077330OCTREOTIDE ACETATESUN PHARMACEUTICAL INDUSTRIES LTD2008-03-04ANDA077330_001Octreotide Prefilled Syringe
Octreotide Injection
7ANDA077331OCTREOTIDE ACETATESUN PHARMACEUTICAL INDUSTRIES LTD2008-03-04ANDA077331_001Octreotide Prefilled Syringe
Octreotide Injection
8ANDA077372OCTREOTIDE ACETATESUN PHARMACEUTICAL INDUSTRIES LTD2007-08-14ANDA077372_001, ANDA077372_002, ANDA077372_003Octreotide Prefilled Syringe
Octreotide Injection
9ANDA077373OCTREOTIDE ACETATESUN PHARMACEUTICAL INDUSTRIES LTD2007-08-14ANDA077373_001, ANDA077373_002Octreotide Prefilled Syringe
Octreotide Injection
10ANDA077450OCTREOTIDE ACETATEFRESENIUS KABI USA LLC2006-02-10ANDA077450_001, ANDA077450_002Octreotide Prefilled Syringe
Octreotide Injection
11ANDA077457OCTREOTIDE ACETATE (PRESERVATIVE FREE)FRESENIUS KABI USA LLC2006-02-10ANDA077457_001, ANDA077457_002, ANDA077457_003Octreotide Prefilled Syringe
Octreotide Injection
12ANDA079198OCTREOTIDE ACETATE (PRESERVATIVE FREE)MYLAN INSTITUTIONAL LLC2011-02-10ANDA079198_001, ANDA079198_002, ANDA079198_003Octreotide Prefilled Syringe
Octreotide Injection
13ANDA090834OCTREOTIDE ACETATE (PRESERVATIVE FREE)SAGENT PHARMACEUTICALS INC2013-11-12ANDA090834_001, ANDA090834_002, ANDA090834_003Octreotide Prefilled Syringe
Octreotide Injection
14ANDA090985OCTREOTIDE ACETATE (PRESERVATIVE FREE)WOCKHARDT USA INC2011-05-11ANDA090985_001, ANDA090985_002, ANDA090985_003Octreotide Prefilled Syringe
Octreotide Injection
15ANDA090986OCTREOTIDE ACETATEWOCKHARDT USA INC2011-05-11ANDA090986_001, ANDA090986_002Octreotide Prefilled Syringe
Octreotide Injection
16ANDA091041OCTREOTIDE ACETATESAGENT PHARMACEUTICALS INC2013-11-12ANDA091041_001, ANDA091041_002Octreotide Prefilled Syringe
Octreotide Injection
17NDA019667SANDOSTATINNOVARTIS PHARMACEUTICALS CORP1988-10-21p5753618NDA019667_001, NDA019667_002, NDA019667_003, NDA019667_004, NDA019667_005Octreotide Prefilled Syringe
Octreotide Injection
18NDA021008SANDOSTATIN LARNOVARTIS PHARMACEUTICALS CORP1998-11-25p5922338, SUBSTANCE
p5922682, SUBSTANCE
p5688530, ACROMEGALY
NDA021008_001, NDA021008_002, NDA021008_003Octreotide Prefilled Syringe
Octreotide Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075957_001RXOCTREOTIDE ACETATE (EQ 0.05MG BASE/ML)INJECTIONFalseAP2005-10-03OCTREOTIDE ACETATE
2ANDA075957_002RXOCTREOTIDE ACETATE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2005-10-03OCTREOTIDE ACETATE
3ANDA075957_003RXOCTREOTIDE ACETATE (EQ 0.5MG BASE/ML)INJECTIONFalseAP2005-10-03OCTREOTIDE ACETATE
4ANDA075959_001RXOCTREOTIDE ACETATE (EQ 0.2MG BASE/ML)INJECTIONFalseAP2005-11-21OCTREOTIDE ACETATE
5ANDA075959_002RXOCTREOTIDE ACETATE (EQ 1MG BASE/ML)INJECTIONFalseAP2005-11-21OCTREOTIDE ACETATE
6ANDA076313_001RXOCTREOTIDE ACETATE (EQ 0.05MG BASE/ML)INJECTIONTrueAP2005-03-28OCTREOTIDE ACETATE (PRESERVATIVE FREE)
7ANDA076313_002RXOCTREOTIDE ACETATE (EQ 0.5MG BASE/ML)INJECTIONTrueAP2005-03-28OCTREOTIDE ACETATE (PRESERVATIVE FREE)
8ANDA076313_003RXOCTREOTIDE ACETATE (EQ 0.1MG BASE/ML)INJECTIONTrueAP2005-03-28OCTREOTIDE ACETATE (PRESERVATIVE FREE)
9ANDA076330_001RXOCTREOTIDE ACETATE (EQ 0.2MG BASE/ML)INJECTIONTrueAP2005-04-08OCTREOTIDE ACETATE
10ANDA076330_002RXOCTREOTIDE ACETATE (EQ 1MG BASE/ML)INJECTIONTrueAP2005-04-08OCTREOTIDE ACETATE
11ANDA077329_001RXOCTREOTIDE ACETATE (EQ 0.05MG BASE/ML)INJECTIONFalseAP2008-03-04OCTREOTIDE ACETATE
12ANDA077329_002RXOCTREOTIDE ACETATE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2008-03-04OCTREOTIDE ACETATE
13ANDA077329_003RXOCTREOTIDE ACETATE (EQ 0.5MG BASE/ML)INJECTIONFalseAP2008-03-04OCTREOTIDE ACETATE
14ANDA077330_001RXOCTREOTIDE ACETATE (EQ 0.2MG BASE/ML)INJECTIONFalseAP2008-03-04OCTREOTIDE ACETATE
15ANDA077331_001RXOCTREOTIDE ACETATE (EQ 1MG BASE/ML)INJECTIONFalseAP2008-03-04OCTREOTIDE ACETATE
16ANDA077372_001RXOCTREOTIDE ACETATE (EQ 0.05MG BASE/ML)INJECTIONFalseAP2007-08-14OCTREOTIDE ACETATE
17ANDA077372_002RXOCTREOTIDE ACETATE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2007-08-14OCTREOTIDE ACETATE
18ANDA077372_003RXOCTREOTIDE ACETATE (EQ 0.5MG BASE/ML)INJECTIONFalseAP2007-08-14OCTREOTIDE ACETATE
19ANDA077373_001RXOCTREOTIDE ACETATE (EQ 0.2MG BASE/ML)INJECTIONFalseAP2007-08-14OCTREOTIDE ACETATE
20ANDA077373_002RXOCTREOTIDE ACETATE (EQ 1MG BASE/ML)INJECTIONFalseAP2007-08-14OCTREOTIDE ACETATE
21ANDA077450_001RXOCTREOTIDE ACETATE (EQ 0.2MG BASE/ML)INJECTIONFalseAP2006-02-10OCTREOTIDE ACETATE
22ANDA077450_002RXOCTREOTIDE ACETATE (EQ 1MG BASE/ML)INJECTIONFalseAP2006-02-10OCTREOTIDE ACETATE
23ANDA077457_001RXOCTREOTIDE ACETATE (EQ 0.05MG BASE/ML)INJECTIONFalseAP2006-02-10OCTREOTIDE ACETATE (PRESERVATIVE FREE)
24ANDA077457_002RXOCTREOTIDE ACETATE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2006-02-10OCTREOTIDE ACETATE (PRESERVATIVE FREE)
25ANDA077457_003RXOCTREOTIDE ACETATE (EQ 0.5MG BASE/ML)INJECTIONFalseAP2006-02-10OCTREOTIDE ACETATE (PRESERVATIVE FREE)
26ANDA079198_001RXOCTREOTIDE ACETATE (EQ 0.05MG BASE/ML)INJECTIONFalseAP2011-02-10OCTREOTIDE ACETATE (PRESERVATIVE FREE)
27ANDA079198_002RXOCTREOTIDE ACETATE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2011-02-10OCTREOTIDE ACETATE (PRESERVATIVE FREE)
28ANDA079198_003RXOCTREOTIDE ACETATE (EQ 0.5MG BASE/ML)INJECTIONFalseAP2011-02-10OCTREOTIDE ACETATE (PRESERVATIVE FREE)
29ANDA090834_001RXOCTREOTIDE ACETATE (EQ 0.05MG BASE/ML)INJECTIONFalseAP2013-11-12OCTREOTIDE ACETATE (PRESERVATIVE FREE)
30ANDA090834_002RXOCTREOTIDE ACETATE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2013-11-12OCTREOTIDE ACETATE (PRESERVATIVE FREE)
31ANDA090834_003RXOCTREOTIDE ACETATE (EQ 0.5MG BASE/ML)INJECTIONFalseAP2013-11-12OCTREOTIDE ACETATE (PRESERVATIVE FREE)
32ANDA090985_001RXOCTREOTIDE ACETATE (EQ 0.05MG BASE/ML)INJECTIONFalseAP2011-05-11OCTREOTIDE ACETATE (PRESERVATIVE FREE)
33ANDA090985_002RXOCTREOTIDE ACETATE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2011-05-11OCTREOTIDE ACETATE (PRESERVATIVE FREE)
34ANDA090985_003RXOCTREOTIDE ACETATE (EQ 0.5MG BASE/ML)INJECTIONFalseAP2011-05-11OCTREOTIDE ACETATE (PRESERVATIVE FREE)
35ANDA090986_001RXOCTREOTIDE ACETATE (EQ 0.2MG BASE/ML)INJECTIONFalseAP2011-05-11OCTREOTIDE ACETATE
36ANDA090986_002RXOCTREOTIDE ACETATE (EQ 1MG BASE/ML)INJECTIONFalseAP2011-05-11OCTREOTIDE ACETATE
37ANDA091041_001RXOCTREOTIDE ACETATE (EQ 0.2MG BASE/ML)INJECTIONFalseAP2013-11-12OCTREOTIDE ACETATE
38ANDA091041_002RXOCTREOTIDE ACETATE (EQ 1MG BASE/ML)INJECTIONFalseAP2013-11-12OCTREOTIDE ACETATE
39NDA019667_001RXOCTREOTIDE ACETATE (EQ 0.05MG BASE/ML)INJECTIONTrueAP1988-10-21SANDOSTATIN
40NDA019667_002RXOCTREOTIDE ACETATE (EQ 0.1MG BASE/ML)INJECTIONTrueAP1988-10-21SANDOSTATIN
41NDA019667_003RXOCTREOTIDE ACETATE (EQ 0.5MG BASE/ML)INJECTIONTrueAP1988-10-21SANDOSTATIN
42NDA019667_004RXOCTREOTIDE ACETATE (EQ 0.2MG BASE/ML)INJECTIONTrueAP1991-06-12SANDOSTATIN
43NDA019667_005RXOCTREOTIDE ACETATE (EQ 1MG BASE/ML)INJECTIONTrueAP1991-06-12SANDOSTATIN
44NDA021008_001RXOCTREOTIDE ACETATE (EQ 10MG BASE/VIAL)INJECTIONFalse1998-11-25SANDOSTATIN LAR
45NDA021008_002RXOCTREOTIDE ACETATE (EQ 20MG BASE/VIAL)INJECTIONFalse1998-11-25SANDOSTATIN LAR
46NDA021008_003RXOCTREOTIDE ACETATE (EQ 30MG BASE/VIAL)INJECTIONTrue1998-11-25SANDOSTATIN LAR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5688530 (view patent)2014-11-18NDA021008Octreotide Prefilled Syringe
Octreotide Injection
2p5753618 (view patent)2015-05-19NDA019667Octreotide Prefilled Syringe
Octreotide Injection
3p5922338 (view patent)2016-07-13NDA021008Octreotide Prefilled Syringe
Octreotide Injection
4p5922682 (view patent)2016-07-13NDA021008Octreotide Prefilled Syringe
Octreotide Injection

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
120917b50-512f-45c9-a446-1e8a509f3687 (view SPL)Octreotide Acetate Injection33013311332133333343Rx onlyprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-09-033007033333, 007033343, 007033301, 007033311, 007033321Octreotide Injection
23cf0c341-60a5-466b-b907-5826e8e0874a (view SPL)Octreotide Acetate InjectionprescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-155627560350, 627560352, 627560093, 627560094, 627560095, 627560348, 627560349, 627560351Octreotide Injection
34e2c9856-1836-49f0-9472-4dbeeb408f39 (view SPL)SandostatinprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2012-03-157000780180, 000780181, 000780182, 000780183, 000780184Octreotide Injection
476146a72-05fe-4804-a9c2-df573c97d9cb (view SPL)Octreotide Acetate InjectionprescriptionHuman PrescriptionSandoz Inc2013-07-2912007813164, 007813165
5c228ff95-7052-465f-9344-22915b2ce4c8 (view SPL)Octreotide Acetate InjectionprescriptionHuman PrescriptionSagent Pharmaceuticals2014-09-198250210454, 250210455, 250210451, 250210452, 250210453Octreotide Injection
6f278f0d8-4062-420a-97c3-3a8b88253a08 (view SPL)Octreotide Acetate InjectionprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-10-112633230378, 633230379, 633230365, 633230376, 633230377Octreotide Injection

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII