Doxycycline Injection

Brand(s)
Doxy
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Institutional Llc (2014-06-24)
Oldest Current Product
2000-10-17
License(s)
ANDA
RxNORM
INJECTION\DOXYCYCLINE
FDAOB
INJECTION\INJECTION\DOXYCYCLINE HYCLATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DOXYCYCLINE HYCLATE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DOXYCYCLINE ANHYDROUS

product(s) by strength(s)

doxycycline hyclate 100 mg injection

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690104ANDAPfizer Labs2012-08-21DOXYCYCLINE HYCLATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0914062b063ec6-0b25-4ddd-9dd8-34c1641d9e85
2633230130DoxyANDAApp Pharmaceuticals, Llc2000-10-17DOXYCYCLINE HYCLATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA062475a7b754e2-a028-469d-ba95-8412ef03ab0a, b0894010-39bd-459f-8563-cf83343105ee, b256babb-1bba-4b0c-8837-d13ba3af7659
3674570437ANDAMylan Institutional Llc2012-08-21DOXYCYCLINE HYCLATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091406878a1cf9-31a9-425b-910d-042ed91e98d5

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840028DoxyANDAGeneral Injecatables & Vaccines, Inc2012-02-22DOXYCYCLINE HYCLATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION633230130ANDA0624755df74bff-1e68-460c-8327-ee7ffd2471e8
2525840110ANDAGeneral Injecatables & Vaccines, Inc2010-08-01DOXYCYCLINE HYCLATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION553900110ANDA062569f9b9ca8a-5cfc-446a-8330-36cf96625a57

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA061953DOXYCHEL HYCLATETrueRACHELLE LABORATORIES INCANDA061953_001
2ANDA062450DOXYCYCLINETrueEUROHEALTH INTERNATIONAL SARL1983-10-27ANDA062450_001, ANDA062450_002
3ANDA062475DOXY 100FRESENIUS KABI USA LLC1983-12-09ANDA062475_001, ANDA062475_002
4ANDA062569DOXYCYCLINEEUROHEALTH INTERNATIONAL SARL1988-03-09ANDA062569_001, ANDA062569_002
5ANDA062992DOXYCYCLINE HYCLATETrueHIKMA MAPLE LTD1989-02-16ANDA062992_001, ANDA062992_002
6ANDA091406DOXYCYCLINEMYLAN LABORATORIES LTD2012-08-21ANDA091406_001
7NDA050442VIBRAMYCINTruePFIZER LABORATORIES DIV PFIZER INCNDA050442_001, NDA050442_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA061953_001discontinuedDOXYCYCLINE HYCLATE (EQ 100MG BASE/VIAL)INJECTIONFalseDOXYCHEL HYCLATE
2ANDA062450_001discontinuedDOXYCYCLINE HYCLATE (EQ 100MG BASE/VIAL)INJECTIONFalse1983-10-27DOXYCYCLINE
3ANDA062450_002discontinuedDOXYCYCLINE HYCLATE (EQ 200MG BASE/VIAL)INJECTIONFalse1983-10-27DOXYCYCLINE
4ANDA062475_001RXDOXYCYCLINE HYCLATE (EQ 100MG BASE/VIAL)INJECTIONTrueAP1983-12-09DOXY 100
5ANDA062475_002RXDOXYCYCLINE HYCLATE (EQ 200MG BASE/VIAL)INJECTIONTrue1983-12-09DOXY 100
6ANDA062569_001RXDOXYCYCLINE HYCLATE (EQ 100MG BASE/VIAL)INJECTIONTrueAP1988-03-09DOXYCYCLINE
7ANDA062569_002discontinuedDOXYCYCLINE HYCLATE (EQ 200MG BASE/VIAL)INJECTIONFalse1988-03-09DOXYCYCLINE
8ANDA062992_001discontinuedDOXYCYCLINE HYCLATE (EQ 100MG BASE/VIAL)INJECTIONFalse1989-02-16DOXYCYCLINE HYCLATE
9ANDA062992_002discontinuedDOXYCYCLINE HYCLATE (EQ 200MG BASE/VIAL)INJECTIONFalse1989-02-16DOXYCYCLINE HYCLATE
10ANDA091406_001RXDOXYCYCLINE HYCLATE (EQ 100MG BASE/VIAL)INJECTIONFalseAP2012-08-21DOXYCYCLINE
11NDA050442_001discontinuedDOXYCYCLINE HYCLATE (EQ 200MG BASE/VIAL)INJECTIONFalseVIBRAMYCIN
12NDA050442_002discontinuedDOXYCYCLINE HYCLATE (EQ 100MG BASE/VIAL)INJECTIONFalseVIBRAMYCIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12b063ec6-0b25-4ddd-9dd8-34c1641d9e85 (view SPL)DOXYCYCLINE FOR INJECTION, USPprescriptionHuman PrescriptionPfizer LabsMANUFACTURE2012-11-022000690104
25df74bff-1e68-460c-8327-ee7ffd2471e8 (view SPL)Doxy 100 Doxycycline for Injection, USP 100mg SDVprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-02-221525840028
3878a1cf9-31a9-425b-910d-042ed91e98d5 (view SPL)DOXYCYCLINE FOR INJECTION, USPprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-06-243674570437
4a7b754e2-a028-469d-ba95-8412ef03ab0a (view SPL)Doxycycline for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-11-181633230130
5b0894010-39bd-459f-8563-cf83343105ee (view SPL)Doxycycline for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-04-154633230130
6b256babb-1bba-4b0c-8837-d13ba3af7659 (view SPL)Doxycycline for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-08-122633230130
7f9b9ca8a-5cfc-446a-8330-36cf96625a57 (view SPL)Doxycycline 100 mg Injection, USP Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-252525840110

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