Erythromycin Topical Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. (2014-07-14)
Oldest Current Product
1987-10-23
License(s)
ANDA
RxNORM
TOPICAL SOLUTION\ERYTHROMYCIN
FDAOB
TOPICAL\SOLUTION\ERYTHROMYCIN
SPL Active
TOPICAL\SOLUTION\ERYTHROMYCIN
SPL Moiety
TOPICAL\SOLUTION\ERYTHROMYCIN

product(s) by strength(s)

erythromycin 20 mg/ml topical solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680215ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.1997-09-30ERYTHROMYCINTOPICALSOLUTIONANDA064187992be13e-2409-4799-96ef-731ac3bf3973
2458020038ANDAPerrigo New York Inc2011-12-19ERYTHROMYCINTOPICALSOLUTIONANDA06303840edf1bd-42bb-4662-aff6-01fcc133c05d
3604320671ANDAMorton Grove Pharmaceuticals, Inc.1987-10-23ERYTHROMYCINTOPICALSOLUTIONANDA06282581312193-82d8-49f8-b381-8fb866b2ec76

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548680946ANDAPhysicians Total Care, Inc.1996-03-29ERYTHROMYCINTOPICALSOLUTION001680215ANDA064187018c94b5-8379-4b08-a18c-fad9c0219c0b

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062290ERYDERMTrueARBOR PHARMACEUTICALS INCANDA062290_001
2ANDA062326ERYTHROMYCINTrueALPHARMA US PHARMACEUTICALS DIVISION1982-04-19ANDA062326_001
3ANDA062327ERYTHROMYCINTrueALPHARMA US PHARMACEUTICALS DIVISION1982-04-19ANDA062327_001
4ANDA062328ERYTHROMYCINTrueALPHARMA US PHARMACEUTICALS DIVISION1982-04-19ANDA062328_001
5ANDA062342ERYTHROMYCINTrueALPHARMA US PHARMACEUTICALS DIVISION1982-02-25ANDA062342_001
6ANDA062405A/T/STrueTARO PHARMACEUTICALS NORTH AMERICA INC1982-11-18ANDA062405_001
7ANDA062436T-STATTrueWESTWOOD SQUIBB PHARMACEUTICALS INC1983-03-09ANDA062436_001
8ANDA062468C-SOLVE-2FOUGERA PHARMACEUTICALS INC1985-07-03ANDA062468_001
9ANDA062485ERYTHROMYCINTruePHARMAFAIR INC1984-07-11ANDA062485_001
10ANDA062508ERYMAXTrueMERZ PHARMACEUTICALS LLC1985-07-11ANDA062508_002
11ANDA062522SANSACTrueDOW PHARMACEUTICAL SCIENCES1985-01-24ANDA062522_001
12ANDA062616ERYTHROMYCINTruePHARMAFAIR INC1985-07-25ANDA062616_001
13ANDA062687ERYTHRA-DERMPADDOCK LABORATORIES LLC1988-02-05ANDA062687_001
14ANDA062825ERYTHROMYCINWOCKHARDT EU OPERATIONS (SWISS) AG1987-10-23ANDA062825_001
15ANDA062957ERYTHROMYCINTrueALPHARMA US PHARMACEUTICALS DIVISION1988-07-21ANDA062957_001
16ANDA063038ERYTHROMYCINPERRIGO NEW YORK INC1991-01-11ANDA063038_001
17ANDA064039ERYTHROMYCINTrueBAUSCH AND LOMB PHARMACEUTICALS INC1994-01-27ANDA064039_001
18ANDA064101ERYTHRO-STATINHI TECH PHARMACAL CO INC1996-10-22ANDA064101_001
19ANDA064127ERYTHROMYCINTrueRENAISSANCE PHARMA US HOLDINGS INC1997-02-14ANDA064127_001
20ANDA064187ERYTHROMYCINFOUGERA PHARMACEUTICALS INC1997-09-30ANDA064187_001
21NDA050526STATICINTrueWESTWOOD SQUIBB PHARMACEUTICALS INCNDA050526_001
22NDA050532ERYTHROMYCINTrueELI LILLY AND CONDA050532_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062290_001discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalseERYDERM
2ANDA062326_001discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalse1982-04-19ERYTHROMYCIN
3ANDA062327_001discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalse1982-04-19ERYTHROMYCIN
4ANDA062328_001discontinuedERYTHROMYCIN (1.5%)TOPICALSOLUTIONFalse1982-04-19ERYTHROMYCIN
5ANDA062342_001discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalse1982-02-25ERYTHROMYCIN
6ANDA062405_001discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalse1982-11-18A/T/S
7ANDA062436_001discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalse1983-03-09T-STAT
8ANDA062468_001RXERYTHROMYCIN (2%)TOPICALSOLUTIONFalseAT1985-07-03C-SOLVE-2
9ANDA062485_001discontinuedERYTHROMYCIN (1.5%)TOPICALSOLUTIONFalse1984-07-11ERYTHROMYCIN
10ANDA062508_002discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalse1985-07-11ERYMAX
11ANDA062522_001discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalse1985-01-24SANSAC
12ANDA062616_001discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalse1985-07-25ERYTHROMYCIN
13ANDA062687_001RXERYTHROMYCIN (2%)TOPICALSOLUTIONFalseAT1988-02-05ERYTHRA-DERM
14ANDA062825_001RXERYTHROMYCIN (2%)TOPICALSOLUTIONFalseAT1987-10-23ERYTHROMYCIN
15ANDA062957_001discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalse1988-07-21ERYTHROMYCIN
16ANDA063038_001RXERYTHROMYCIN (2%)TOPICALSOLUTIONFalseAT1991-01-11ERYTHROMYCIN
17ANDA064039_001discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalse1994-01-27ERYTHROMYCIN
18ANDA064101_001RXERYTHROMYCIN (2%)TOPICALSOLUTIONFalseAT1996-10-22ERYTHRO-STATIN
19ANDA064127_001discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalse1997-02-14ERYTHROMYCIN
20ANDA064187_001RXERYTHROMYCIN (2%)TOPICALSOLUTIONTrueAT1997-09-30ERYTHROMYCIN
21NDA050526_001discontinuedERYTHROMYCIN (1.5%)TOPICALSOLUTIONFalseSTATICIN
22NDA050532_001discontinuedERYTHROMYCIN (2%)TOPICALSOLUTIONFalseERYTHROMYCIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1018c94b5-8379-4b08-a18c-fad9c0219c0b (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-07-291548680946
240edf1bd-42bb-4662-aff6-01fcc133c05d (view SPL)Erythromycin Topical Solution USP, 2%prescriptionHuman PrescriptionPerrigo New York IncMANUFACTURE2014-10-084458020038
381312193-82d8-49f8-b381-8fb866b2ec76 (view SPL)ERYTHROMYCIN TOPICAL SOLUTION, USP 2%prescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2014-10-283604320671
4992be13e-2409-4799-96ef-731ac3bf3973 (view SPL)ERYTHROMYCIN TOPICAL SOLUTION USP 2%prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2014-07-144001680215

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