Estradiol Injectable Solution

Brand(s)
Delestrogen, Depo-estradiol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Inc. (2015-06-29)
Oldest Current Product
1979-08-15
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTABLE SOLUTION\ESTRADIOL
FDAOB
INJECTION\INJECTION\ESTRADIOL CYPIONATE\rdfq
INJECTION\INJECTION\ESTRADIOL VALERATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\ESTRADIOL VALERATE
INTRAMUSCULAR\INJECTION\ESTRADIOL CYPIONATE
INTRAMUSCULAR\INJECTION\ESTRADIOL VALERATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\ESTRADIOL
INTRAMUSCULAR\INJECTION\ESTRADIOL
INTRAMUSCULAR\INJECTION\ESTRADIOL CYPIONATE

product(s) by strength(s)

estradiol 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230110DelestrogenNDAPar Pharmaceutical Inc.2007-11-01ESTRADIOL VALERATEINTRAMUSCULARINJECTIONNDA009402e8f94df9-0692-4462-a7f0-fe019a0a3f07

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230134NDA AUTHORIZED GENERICPar Pharmaceutical Inc.2012-06-01ESTRADIOL VALERATEINTRAMUSCULARINJECTIONNDA0094025d29dc3b-e19a-4924-8ad4-85018f0ab395

estradiol 20 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230111DelestrogenNDAPar Pharmaceutical Inc.2007-11-01ESTRADIOL VALERATEINTRAMUSCULARINJECTIONNDA009402e8f94df9-0692-4462-a7f0-fe019a0a3f07

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005740870ANDAPaddock Laboratories, Llc2010-03-31ESTRADIOL VALERATEINTRAMUSCULARINJECTION, SOLUTIONANDA090920c5f32941-3427-4a38-bc3d-38337b41d9d3
2420230135NDA AUTHORIZED GENERICPar Pharmaceutical Inc.2012-06-01ESTRADIOL VALERATEINTRAMUSCULARINJECTIONNDA0094025d29dc3b-e19a-4924-8ad4-85018f0ab395

estradiol 40 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230112DelestrogenNDAPar Pharmaceutical Inc.2007-11-01ESTRADIOL VALERATEINTRAMUSCULARINJECTIONNDA009402e8f94df9-0692-4462-a7f0-fe019a0a3f07

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005740872ANDAPaddock Laboratories, Llc2010-03-31ESTRADIOL VALERATEINTRAMUSCULARINJECTION, SOLUTIONANDA090920c5f32941-3427-4a38-bc3d-38337b41d9d3
2420230136NDA AUTHORIZED GENERICPar Pharmaceutical Inc.2012-06-01ESTRADIOL VALERATEINTRAMUSCULARINJECTIONNDA0094025d29dc3b-e19a-4924-8ad4-85018f0ab395

estradiol 5 mg/ml injectable solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090271Depo-estradiolANDAPharmacia And Upjohn Company1979-08-15ESTRADIOL CYPIONATEINTRAMUSCULARINJECTIONANDA0854709a4229fd-fecd-4ac1-9c4f-6d442533457f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548681729Depo-estradiolANDAPhysicians Total Care, Inc.1998-10-16ESTRADIOL CYPIONATEINTRAMUSCULARINJECTION00009027101ANDA0854704165ef14-8dfc-4165-859c-dcf06174d69c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040628ESTRADIOL VALERATETrueSANDOZ CANADA INC2007-10-04ANDA040628_001, ANDA040628_002, ANDA040628_003
2ANDA083546ESTRADIOL VALERATETrueWATSON LABORATORIES INCANDA083546_001
3ANDA083547ESTRADIOL VALERATETrueWATSON LABORATORIES INCANDA083547_001
4ANDA083714ESTRADIOL VALERATETrueWATSON LABORATORIES INCANDA083714_001
5ANDA085470DEPO-ESTRADIOLPHARMACIA AND UPJOHN COANDA085470_001, ANDA085470_002, ANDA085470_003
6ANDA085620ESTRADIOL CYPIONATETrueWATSON LABORATORIES INCANDA085620_001
7ANDA090920ESTRADIOL VALERATELUITPOLD PHARMACEUTICALS INC2010-01-19ANDA090920_001, ANDA090920_002
8NDA009402DELESTROGENPAR STERILE PRODUCTS LLCNDA009402_002, NDA009402_003, NDA009402_004

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040628_001discontinuedESTRADIOL VALERATE (10MG/ML)INJECTIONFalse2007-10-04ESTRADIOL VALERATE
2ANDA040628_002discontinuedESTRADIOL VALERATE (20MG/ML)INJECTIONFalse2007-10-04ESTRADIOL VALERATE
3ANDA040628_003discontinuedESTRADIOL VALERATE (40MG/ML)INJECTIONFalse2007-10-04ESTRADIOL VALERATE
4ANDA083546_001discontinuedESTRADIOL VALERATE (10MG/ML)INJECTIONFalseESTRADIOL VALERATE
5ANDA083547_001discontinuedESTRADIOL VALERATE (20MG/ML)INJECTIONFalseESTRADIOL VALERATE
6ANDA083714_001discontinuedESTRADIOL VALERATE (40MG/ML)INJECTIONFalseESTRADIOL VALERATE
7ANDA085470_001discontinuedESTRADIOL CYPIONATE (1MG/ML)INJECTIONFalseDEPO-ESTRADIOL
8ANDA085470_002discontinuedESTRADIOL CYPIONATE (3MG/ML)INJECTIONFalseDEPO-ESTRADIOL
9ANDA085470_003RXESTRADIOL CYPIONATE (5MG/ML)INJECTIONTrueDEPO-ESTRADIOL
10ANDA085620_001discontinuedESTRADIOL CYPIONATE (5MG/ML)INJECTIONFalseESTRADIOL CYPIONATE
11ANDA090920_001RXESTRADIOL VALERATE (20MG/ML)INJECTIONFalseAO2010-01-19ESTRADIOL VALERATE
12ANDA090920_002RXESTRADIOL VALERATE (40MG/ML)INJECTIONFalseAO2010-01-19ESTRADIOL VALERATE
13NDA009402_002RXESTRADIOL VALERATE (10MG/ML)INJECTIONTrueDELESTROGEN
14NDA009402_003RXESTRADIOL VALERATE (40MG/ML)INJECTIONTrueAODELESTROGEN
15NDA009402_004RXESTRADIOL VALERATE (20MG/ML)INJECTIONTrueAODELESTROGEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14165ef14-8dfc-4165-859c-dcf06174d69c (view SPL)DEPO-ESTRADIOL Estradiol cypionate injection, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-03-021548681729
25d29dc3b-e19a-4924-8ad4-85018f0ab395 (view SPL)Estradiol Valerate Injection, USPprescriptionHuman PrescriptionPar Pharmaceutical Inc.2013-10-183420230134, 420230135, 420230136
39a4229fd-fecd-4ac1-9c4f-6d442533457f (view SPL)DEPO-ESTRADIOL Estradiol cypionate injection, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2013-08-203000090271
4c5f32941-3427-4a38-bc3d-38337b41d9d3 (view SPL)ESTRADIOL VALERATE INJECTION, USPprescriptionHuman PrescriptionPaddock Laboratories, LlcANALYSIS, MANUFACTURE2014-02-263005740870, 005740872
5e8f94df9-0692-4462-a7f0-fe019a0a3f07 (view SPL)DELESTROGEN (estradiol valerate injection, USP)prescriptionHuman PrescriptionPar Pharmaceutical Inc.2015-06-298420230110, 420230111, 420230112

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