Octreotide Prefilled Syringe

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Institutional Llc (2013-03-31)
Oldest Current Product
2013-04-25
License(s)
ANDA
RxNORM
PREFILLED SYRINGE\OCTREOTIDE
FDAOB
INJECTION\INJECTION\OCTREOTIDE ACETATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\OCTREOTIDE ACETATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\OCTREOTIDE

product(s) by strength(s)

1 ml octreotide 0.05 mg/ml prefilled syringe

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1674570239ANDAMylan Institutional Llc2013-04-25OCTREOTIDE ACETATEINTRAVENOUSINJECTION, SOLUTIONANDA0791982d78d5d1-77b2-4da1-98d4-d9c36e743ce2

1 ml octreotide 0.1 mg/ml prefilled syringe

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1674570245ANDAMylan Institutional Llc2013-04-25OCTREOTIDE ACETATEINTRAVENOUSINJECTION, SOLUTIONANDA0791982d78d5d1-77b2-4da1-98d4-d9c36e743ce2

1 ml octreotide 0.5 mg/ml prefilled syringe

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1674570246ANDAMylan Institutional Llc2013-04-25OCTREOTIDE ACETATEINTRAVENOUSINJECTION, SOLUTIONANDA0791982d78d5d1-77b2-4da1-98d4-d9c36e743ce2

application(s)

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

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 Injection
Octreotide Injectable Solution
2p5753618 (view patent)2015-05-19NDA019667Octreotide Injection
Octreotide Injectable Solution
3p5922338 (view patent)2016-07-13NDA021008Octreotide Injection
Octreotide Injectable Solution
4p5922682 (view patent)2016-07-13NDA021008Octreotide Injection
Octreotide Injectable Solution

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
12d78d5d1-77b2-4da1-98d4-d9c36e743ce2 (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2013-03-316674570239, 674570245, 674570246

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