Bacitracin / Polymyxin B Ophthalmic Ointment

Brand(s)
Polycin-B
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bausch & Lomb Incorporated (2013-11-04)
Oldest Current Product
1995-01-30
License(s)
ANDA
RxNORM
OPHTHALMIC OINTMENT\BACITRACIN:POLYMYXIN B
FDAOB
OPHTHALMIC\OINTMENT\BACITRACIN ZINC: POLYMYXIN B SULFATE
SPL Active
OPHTHALMIC\OINTMENT\BACITRACIN ZINC: POLYMYXIN B SULFATE
SPL Moiety
OPHTHALMIC\OINTMENT\BACITRACIN: POLYMYXIN B

product(s) by strength(s)

bacitracin 0.5 unt/mg / polymyxin b 10 unt/mg ophthalmic ointment

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680273ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2008-08-28BACITRACIN ZINC, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA06502258f12018-ef71-4a2b-a6f5-6ec3ac19c353
2005744021Polycin-BANDAPaddock Laboratories, Llc2014-11-12BACITRACIN ZINC, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0650223abbfb58-26d1-460d-a60f-db63c0193a0d
3174780238ANDAAkorn2006-05-08BACITRACIN ZINC, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0640288b750666-18f2-40f5-9fb3-87457001b485
4242080555ANDABausch & Lomb Incorporated2008-04-25BACITRACIN ZINC, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0640461b317249-30eb-4415-8a1c-cfedb4ba3549
5481020004Polycin-BANDAFera Pharmaceuticals2011-07-20BACITRACIN ZINC, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0650227eee57e9-b09c-4316-add2-66b5b06b6e79

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900989ANDAStat Rx Usa Llc1995-01-30BACITRACIN ZINC, POLYMYXIN B SULFATEOPHTHALMICOINTMENT174780238ANDA064028628745db-880e-4663-b064-933f16c47f5c
2216950156ANDARebel Distributors Corp1995-01-30BACITRACIN ZINC, POLYMYXIN B SULFATEOPHTHALMICOINTMENT174780238ANDA064028dc47903e-8d29-43eb-a647-1e8d28232bb9
3422540154ANDARebel Distributors Corp2008-04-25BACITRACIN ZINC, POLYMYXIN B SULFATEOPHTHALMICOINTMENT242080555ANDA064046c6c69fa4-d7be-4c09-b7fa-53c40fad78a7
4499990406ANDALake Erie Medical Dba Quality Care Products Llc1995-01-30BACITRACIN ZINC, POLYMYXIN B SULFATEOPHTHALMICOINTMENT174780238ANDA0640281e74b67a-1cf4-4358-8edd-e0e5c492be7c
5545693570ANDAA-S Medication Solutions Llc2006-05-08BACITRACIN ZINC, POLYMYXIN B SULFATEOPHTHALMICOINTMENT174780238ANDA064028c88a3c1c-2906-4a76-a49e-12cb88c9a85b
6548681199ANDAPhysicians Total Care, Inc.2004-11-12BACITRACIN ZINC, POLYMYXIN B SULFATEOPHTHALMICOINTMENT17478023835ANDA064028064c3812-c664-40e3-a21b-b841757600d0
7619190989ANDADirect Rx2014-01-01BACITRACIN ZINC, POLYMYXIN B SULFATEOPHTHALMICOINTMENT174780238ANDA0640281df13524-99f3-416c-94f8-4f6e16eb1c7e

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA061229POLYSPORINTrueMONARCH PHARMACEUTICALS INCANDA061229_001
2ANDA062430OCUMYCINTruePHARMAFAIR INC1983-04-08ANDA062430_001
3ANDA064028BACITRACIN ZINC AND POLYMYXIN B SULFATEAKORN INC1995-01-30ANDA064028_001
4ANDA064046BACITRACIN ZINC AND POLYMYXIN B SULFATEBAUSCH AND LOMB PHARMACEUTICALS INC1995-01-26ANDA064046_001
5ANDA065022BACITRACIN ZINC AND POLYMYXIN B SULFATEPERRIGO CO TENNESSEE INC2002-02-27ANDA065022_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA061229_001discontinuedPOLYMYXIN B SULFATE (10,000 UNITS/GM), BACITRACIN ZINC (500 UNITS/GM)OPHTHALMICOINTMENTFalsePOLYSPORIN
2ANDA062430_001discontinuedBACITRACIN ZINC (500 UNITS/GM), POLYMYXIN B SULFATE (10,000 UNITS/GM)OPHTHALMICOINTMENTFalse1983-04-08OCUMYCIN
3ANDA064028_001RXPOLYMYXIN B SULFATE (10,000 UNITS/GM), BACITRACIN ZINC (500 UNITS/GM)OPHTHALMICOINTMENTFalseAT1995-01-30BACITRACIN ZINC AND POLYMYXIN B SULFATE
4ANDA064046_001RXBACITRACIN ZINC (500 UNITS/GM), POLYMYXIN B SULFATE (10,000 UNITS/GM)OPHTHALMICOINTMENTTrueAT1995-01-26BACITRACIN ZINC AND POLYMYXIN B SULFATE
5ANDA065022_001RXBACITRACIN ZINC (500 UNITS/GM), POLYMYXIN B SULFATE (10,000 UNITS/GM)OPHTHALMICOINTMENTFalseAT2002-02-27BACITRACIN ZINC AND POLYMYXIN B SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1064c3812-c664-40e3-a21b-b841757600d0 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-11-301548681199
21b317249-30eb-4415-8a1c-cfedb4ba3549 (view SPL)Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP (Sterile)prescriptionHuman PrescriptionBausch & Lomb IncorporatedAPI MANUFACTURE, MANUFACTURE2013-11-044242080555
31df13524-99f3-416c-94f8-4f6e16eb1c7e (view SPL)AK-POLY-BACprescriptionHuman PrescriptionDirect Rxrelabel2014-05-301619190989
41e74b67a-1cf4-4358-8edd-e0e5c492be7c (view SPL)Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, SterileprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcRELABEL2012-06-283883499990406
53abbfb58-26d1-460d-a60f-db63c0193a0d (view SPL)Polycin bacitracin zinc and polymyxin B sulfate Ophthalmic Ointment USP STERILE Rx OnlyprescriptionHuman PrescriptionPaddock Laboratories, Llc2014-11-181005744021
658f12018-ef71-4a2b-a6f5-6ec3ac19c353 (view SPL)BACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINTMENT, USPprescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.ANALYSIS, MANUFACTURE2009-05-084001680273
7628745db-880e-4663-b064-933f16c47f5c (view SPL)BACITRACIN ZINC AND POLYMYXIN B SULFATE ointment [Akorn, Inc.]prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-08-261165900989
87eee57e9-b09c-4316-add2-66b5b06b6e79 (view SPL)POLYCINprescriptionHuman PrescriptionFera Pharmaceuticals2011-07-211481020004
98b750666-18f2-40f5-9fb3-87457001b485 (view SPL)Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, SterileprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2012-07-062174780238
10c6c69fa4-d7be-4c09-b7fa-53c40fad78a7 (view SPL)Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP (Sterile)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-02-161422540154
11c88a3c1c-2906-4a76-a49e-12cb88c9a85b (view SPL)Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, SterileprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-10-261545693570
12dc47903e-8d29-43eb-a647-1e8d28232bb9 (view SPL)Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, SterileprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-091216950156

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