Bacitracin Ophthalmic Ointment

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Paddock Laboratories, Llc (2013-12-26)
Oldest Current Product
1994-04-29
License(s)
ANDA
RxNORM
OPHTHALMIC OINTMENT\BACITRACIN
FDAOB
OPHTHALMIC\OINTMENT\BACITRACIN
SPL Active
OPHTHALMIC\OINTMENT\BACITRACIN
SPL Moiety
OPHTHALMIC\OINTMENT\BACITRACIN

product(s) by strength(s)

bacitracin 0.5 unt/mg ophthalmic ointment

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005744022ANDAPaddock Laboratories, Llc2014-03-10BACITRACINOPHTHALMICOINTMENTANDA0612126ed2f2bd-9d2f-46af-a44c-95a02ca034de
2481020007ANDAFera Pharmaceuticals2010-01-11BACITRACINOPHTHALMICOINTMENTANDA061212b2983ec7-5f63-4909-891b-92214d3a637f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422540003ANDARebel Distributors Corp2010-01-11BACITRACINOPHTHALMICOINTMENT481020007ANDA061212a3dc310a-3d75-4e1e-9f9f-ed5c77ff7bfe
2521250454ANDARemedyrepack Inc.2013-06-10BACITRACINOPHTHALMICOINTMENT481020007ANDA061212ae4ea58f-131d-48fe-b192-dd4c3b127df0
3548680649ANDAPhysicians Total Care, Inc.1994-04-29BACITRACINOPHTHALMICOINTMENT48102000735ANDA0612122023b121-67d3-499a-ae7f-526cc9bafbc1

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060687BACITRACINTrueELI LILLY AND COANDA060687_001
2ANDA060734BACIGUENTTruePHARMACIA AND UPJOHN COANDA060734_001
3ANDA061212BACITRACINPERRIGO CO TENNESSEE INCANDA061212_001
4ANDA062158BACITRACINTruePHARMADERM DIV ALTANA INCANDA062158_001
5ANDA062453BACITRACINTruePHARMAFAIR INC1984-03-28ANDA062453_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA060687_001discontinuedBACITRACIN (500 UNITS/GM)OPHTHALMICOINTMENTFalseBACITRACIN
2ANDA060734_001discontinuedBACITRACIN (500 UNITS/GM)OPHTHALMICOINTMENTFalseBACIGUENT
3ANDA061212_001RXBACITRACIN (500 UNITS/GM)OPHTHALMICOINTMENTTrueBACITRACIN
4ANDA062158_001discontinuedBACITRACIN (500 UNITS/GM)OPHTHALMICOINTMENTFalseBACITRACIN
5ANDA062453_001discontinuedBACITRACIN (500 UNITS/GM)OPHTHALMICOINTMENTFalse1984-03-28BACITRACIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12023b121-67d3-499a-ae7f-526cc9bafbc1 (view SPL)BACITRACIN OPHTHALMICOINTMENT USPSTERILEprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-08-261548680649
26ed2f2bd-9d2f-46af-a44c-95a02ca034de (view SPL)Bacitracin Ophthalmic Ointment USPprescriptionHuman PrescriptionPaddock Laboratories, Llc2013-12-261005744022
3a3dc310a-3d75-4e1e-9f9f-ed5c77ff7bfe (view SPL)BACITRACIN OPHTHALMICOINTMENT USPSTERILEprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-11-021422540003
4ae4ea58f-131d-48fe-b192-dd4c3b127df0 (view SPL)BACITRACIN OPHTHALMICOINTMENT USPSTERILEprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-101521250454
5b2983ec7-5f63-4909-891b-92214d3a637f (view SPL)BACITRACIN OPHTHALMICOINTMENT USPSTERILEprescriptionHuman PrescriptionFera Pharmaceuticals2012-09-052481020007

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