Leuprolide Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sun Pharma Global Inc. (2011-05-05)
Oldest Current Product
1998-08-04
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\LEUPROLIDE
FDAOB
INJECTION\INJECTION\LEUPROLIDE ACETATE\rdfq
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\LEUPROLIDE ACETATE
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\LEUPROLIDE

product(s) by strength(s)

leuprolide acetate 5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001857400ANDAEon Labs, Inc.1998-08-04LEUPROLIDE ACETATESUBCUTANEOUSINJECTION, SOLUTIONANDA07472889658d24-2417-4053-a1a4-c38d32db7221
2007034014ANDATeva Parenteral Medicines, Inc2000-11-06ANDA0754711f344d51-4066-47df-9129-cfcf65f086fe
3416160936ANDASun Pharma Global Inc.2009-03-03LEUPROLIDE ACETATESUBCUTANEOUSINJECTION, SOLUTIONANDA0788851727313f-8b7b-44cf-b732-c7bff854898d

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drugin other drug docs
1ANDA074728LEUPROLIDE ACETATESANDOZ INC1998-08-04ANDA074728_001Leuprolide Prefilled Syringe
2ANDA075471LEUPROLIDE ACETATETEVA PHARMACEUTICALS USA2000-10-25ANDA075471_001Leuprolide Prefilled Syringe
3ANDA075721LEUPROLIDE ACETATETrueGENZYME CORPORATION2001-11-29ANDA075721_001Leuprolide Prefilled Syringe
4ANDA078885LEUPROLIDE ACETATESUN PHARMA GLOBAL FZE2009-03-09ANDA078885_001Leuprolide Prefilled Syringe
5NDA019010LUPRONTrueABBVIE ENDOCRINE INC1985-04-09NDA019010_001Leuprolide Prefilled Syringe
6NDA019732LUPRON DEPOTABBVIE ENDOCRINE INC1989-01-26p6036976NDA019732_001Leuprolide Prefilled Syringe
7NDA020011LUPRON DEPOTABBVIE ENDOCRINE INC1990-10-22NDA020011_001, NDA020011_002Leuprolide Prefilled Syringe
8NDA020263LUPRON DEPOT-PEDABBVIE ENDOCRINE INC1993-04-16p6036976, SUBSTANCENEW PRODUCT [2014-08-15]
INFORMATION TO THE CLINICAL STUDIES SECTION OF THE LUPRON DEPOT-PED [2014-10-08]
NDA020263_002, NDA020263_003, NDA020263_004, NDA020263_005, NDA020263_006, NDA020263_007, NDA020263_008Leuprolide Prefilled Syringe
9NDA020517LUPRON DEPOTABBVIE ENDOCRINE INC1995-12-22p7429559, SUBSTANCE
p8815801, SUBSTANCE
p8921326, PALLIATIVE TREATMENT OF PROSTATE CANCER, SUBSTANCE
p6036976, SUBSTANCE
NDA020517_001, NDA020517_002, NDA020517_003Leuprolide Prefilled Syringe
10NDA020708LUPRON DEPOTABBVIE ENDOCRINE INC1997-03-07p6036976NDA020708_001Leuprolide Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074728_001RXLEUPROLIDE ACETATE (1MG/0.2ML)INJECTIONTrueAP1998-08-04LEUPROLIDE ACETATE
2ANDA075471_001RXLEUPROLIDE ACETATE (1MG/0.2ML)INJECTIONFalseAP2000-10-25LEUPROLIDE ACETATE
3ANDA075721_001discontinuedLEUPROLIDE ACETATE (1MG/0.2ML)INJECTIONFalse2001-11-29LEUPROLIDE ACETATE
4ANDA078885_001RXLEUPROLIDE ACETATE (1MG/0.2ML)INJECTIONFalseAP2009-03-09LEUPROLIDE ACETATE
5NDA019010_001discontinuedLEUPROLIDE ACETATE (1MG/0.2ML)INJECTIONFalse1985-04-09LUPRON
6NDA019732_001RXLEUPROLIDE ACETATE (7.5MG/VIAL)INJECTIONTrue1989-01-26LUPRON DEPOT
7NDA020011_001discontinuedLEUPROLIDE ACETATE (3.75MG/VIAL)INJECTIONFalse1990-10-22LUPRON DEPOT
8NDA020011_002RXLEUPROLIDE ACETATE (3.75MG)INJECTIONTrue1995-10-26LUPRON DEPOT
9NDA020263_002RXLEUPROLIDE ACETATE (7.5MG/VIAL)INJECTIONTrue1993-04-16LUPRON DEPOT-PED
10NDA020263_003discontinuedLEUPROLIDE ACETATE (3.75MG/VIAL,7.5MG/VIAL)INJECTIONFalse1993-04-16LUPRON DEPOT-PED
11NDA020263_004discontinuedLEUPROLIDE ACETATE (7.5MG/VIAL,7.5MG/VIAL)INJECTIONFalse1993-04-16LUPRON DEPOT-PED
12NDA020263_005RXLEUPROLIDE ACETATE (11.25MG/VIAL)INJECTIONTrue1994-01-21LUPRON DEPOT-PED
13NDA020263_006RXLEUPROLIDE ACETATE (15MG/VIAL)INJECTIONTrue1994-01-21LUPRON DEPOT-PED
14NDA020263_007RXLEUPROLIDE ACETATE (11.25MG/VIAL)INJECTIONTrue2011-08-15LUPRON DEPOT-PED
15NDA020263_008RXLEUPROLIDE ACETATE (30MG/VIAL)INJECTIONTrue2011-08-15LUPRON DEPOT-PED
16NDA020517_001RXLEUPROLIDE ACETATE (22.5MG/VIAL)INJECTIONTrue1995-12-22LUPRON DEPOT
17NDA020517_002RXLEUPROLIDE ACETATE (30MG/VIAL)INJECTIONTrue1997-05-30LUPRON DEPOT
18NDA020517_003RXLEUPROLIDE ACETATE (45MG/VIAL)INJECTIONFalse2011-06-17LUPRON DEPOT
19NDA020708_001RXLEUPROLIDE ACETATE (11.25MG/VIAL)INJECTIONTrue1997-03-07LUPRON DEPOT

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6036976 (view patent)2016-12-13NDA019732, NDA020263, NDA020517, NDA020708, NDA203696Isopropyl Alcohol Medicated Pad
Leuprolide Prefilled Syringe
2p7429559 (view patent)2019-01-13NDA020517Leuprolide Prefilled Syringe
3p8815801 (view patent)2022-06-28NDA020517Leuprolide Prefilled Syringe
4p8921326 (view patent)2031-02-05NDA020517Leuprolide Prefilled Syringe

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11727313f-8b7b-44cf-b732-c7bff854898d (view SPL)Leuprolide Acetate InjectionprescriptionHuman PrescriptionSun Pharma Global Inc.analysis, manufacture2011-05-057416160936
21f344d51-4066-47df-9129-cfcf65f086fe (view SPL)Leuprolide Acetate InjectionprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-05-158007034014
389658d24-2417-4053-a1a4-c38d32db7221 (view SPL)Leuprolide Acetate InjectionprescriptionHuman PrescriptionEon Labs, Inc.API MANUFACTURE, MANUFACTURE2011-01-0513001857400

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