Erythromycin Ophthalmic Ointment

Brand(s)
Ilotycin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Paddock Laboratories, Llc (2014-10-14)
Oldest Current Product
1994-07-29
License(s)
ANDA
RxNORM
OPHTHALMIC OINTMENT\ERYTHROMYCIN
FDAOB
OPHTHALMIC\OINTMENT\ERYTHROMYCIN
SPL Active
OPHTHALMIC\OINTMENT\ERYTHROMYCIN
SPL Moiety
OPHTHALMIC\OINTMENT\ERYTHROMYCIN

product(s) by strength(s)

erythromycin 0.005 mg/mg ophthalmic ointment

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004047191ANDAHenry Schein Inc.2015-05-13ERYTHROMYCINOPHTHALMICOINTMENTANDA064030ca3a5741-fe73-4fc7-a2a3-35da3b111d26
2005744023IlotycinANDAPaddock Laboratories, Llc2014-10-08ERYTHROMYCINOPHTHALMICOINTMENTANDA062447bd51c566-0d6e-4ff0-8593-8cf9f9d38c4e
3005744024ANDAPaddock Laboratories, Llc2014-05-08ERYTHROMYCINOPHTHALMICOINTMENTANDA06244787b45f99-a4d1-47e0-bbb6-50ca19c10010
4139850605ANDAMwi2015-03-23ERYTHROMYCINOPHTHALMICOINTMENTANDA064030407ff426-4cca-4b65-b2d3-eb2f078bfa39
5174780070ANDAAkorn1996-07-18ERYTHROMYCINOPHTHALMICOINTMENTANDA064030a0353c10-48c9-4d2a-8047-56ea68ace956
6174780824ANDAAkorn2013-03-11ERYTHROMYCINOPHTHALMICOINTMENTANDA064030f4b57b8a-089e-4bbc-bcc7-3a9b9b600930
7242080910ANDABausch & Lomb Incorporated1994-07-29ERYTHROMYCINOPHTHALMICOINTMENTANDA064067061ddd20-94a6-4e3c-ba84-1ebd8529eea6
8481020008ANDAFera Pharmaceuticals2010-01-18ERYTHROMYCINOPHTHALMICOINTMENTANDA062447dc3ee55d-114e-44f2-adb2-fb0c24eba732
9481020016IlotycinANDAFera Pharmaceuticals2010-10-12ERYTHROMYCINOPHTHALMICOINTMENTANDA0624479b1c6c13-4562-4c8e-a8bb-42493dc5cadb

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900090ANDAStat Rx Usa Llc1994-07-29ERYTHROMYCINOPHTHALMICOINTMENT242080910ANDA064067b440cf4c-9d56-4044-9895-1e27df124d06
2216950173ANDARebel Distributors Corp1994-07-29ERYTHROMYCINOPHTHALMICOINTMENT242080910ANDA064067d8b0abac-c32c-4bd0-8247-5c6d6a9fd17f
3499990136ANDALake Erie Medical Dba Quality Care Products Llc2010-01-18ERYTHROMYCINOPHTHALMICOINTMENT481020008ANDA0624471df120f1-778b-4682-9536-2919b782b074
4521250538ANDARemedyrepack Inc.2013-05-06ERYTHROMYCINOPHTHALMICOINTMENT242080910ANDA064067a76acfc7-fcaf-4153-b395-45c7b685178c
5521250800ANDARemedyrepack Inc.2013-12-31ERYTHROMYCINOPHTHALMICOINTMENT174780070ANDA064030e12afac1-56e2-4a1f-8604-471c6d4f9092
6529590301ANDAH.J. Harkins Company, Inc.1994-07-29ERYTHROMYCINOPHTHALMICOINTMENT242080910ANDA06406737fcdb6e-2a9b-464f-9a0e-d3ca323fcb7a
7545691193ANDAA-S Medication Solutions Llc1996-07-18ERYTHROMYCINOPHTHALMICOINTMENT174780070ANDA064030fbdf6021-f53f-41ce-b765-f9328dbfe467
8548680644ANDAPhysicians Total Care, Inc.1994-09-01ERYTHROMYCINOPHTHALMICOINTMENT48102000835ANDA062447c7a804bc-dac8-47dc-b7a8-8f2d384652f2
9550451350ANDADispensing Solutions, Inc.1996-07-18ERYTHROMYCINOPHTHALMICOINTMENT174780070ANDA064030e453b459-9aa7-4873-9b62-340a81aa050b
10551541276ANDACardinal Health1996-07-18ERYTHROMYCINOPHTHALMICOINTMENT174780070ANDA06403095b15fd3-84e3-4d27-8744-b56af5e265a0
11551547850ANDACardinal Health1994-07-29ERYTHROMYCINOPHTHALMICOINTMENT242080910ANDA064067ba4f06c3-ebce-4896-a5cc-59bb5c2cb4e5
12619190090ANDADirect Rx2014-01-01ERYTHROMYCINOPHTHALMICOINTMENT242080910ANDA0640679ac4dcd2-8cac-404d-b651-da74062d30ed
13631870267ANDAProficient Rx Lp1996-07-18ERYTHROMYCINOPHTHALMICOINTMENT174780070ANDA06403062896bec-669e-4f20-a1e4-4f99afd35d32
14687889203ANDAPreferred Pharmaceuticals, Inc.1996-07-18ERYTHROMYCINOPHTHALMICOINTMENT174780070ANDA064030fd185704-9d91-4999-8c87-bd3cb5085e15
15687889328ANDAPreferred Pharmaceuticals, Inc.2015-04-02ERYTHROMYCINOPHTHALMICOINTMENT242080910ANDA064067ee3d806e-65ce-42e1-b170-7b35bcb7b06a
16687889393ANDAPreferred Pharmaceuticals, Inc.2014-07-03ERYTHROMYCINOPHTHALMICOINTMENT005744024ANDA062447d8952bd4-927b-4bdf-8e13-95a08fca2784
17687889666ANDAPreferred Pharmaceuticals, Inc.2013-08-05ERYTHROMYCINOPHTHALMICOINTMENT481020008ANDA0624473c1a0020-f3aa-49c9-89ff-b5c548494619

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062446ERYTHROMYCINTruePHARMADERM DIV ALTANA INC1983-09-26ANDA062446_001
2ANDA062447ERYTHROMYCINPERRIGO CO TENNESSEE INC1983-09-26ANDA062447_001
3ANDA062481ERYTHROMYCINTruePHARMAFAIR INC1984-04-05ANDA062481_001
4ANDA064030ERYTHROMYCINAKORN INC1996-07-18ANDA064030_001
5ANDA064067ERYTHROMYCINBAUSCH AND LOMB PHARMACEUTICALS INC1994-07-29ANDA064067_001
6NDA050368ILOTYCINTrueDISTA PRODUCTS CO DIV ELI LILLY AND CONDA050368_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062446_001discontinuedERYTHROMYCIN (5MG/GM)OPHTHALMICOINTMENTFalse1983-09-26ERYTHROMYCIN
2ANDA062447_001RXERYTHROMYCIN (0.5%)OPHTHALMICOINTMENTTrueAT1983-09-26ERYTHROMYCIN
3ANDA062481_001discontinuedERYTHROMYCIN (5MG/GM)OPHTHALMICOINTMENTFalse1984-04-05ERYTHROMYCIN
4ANDA064030_001RXERYTHROMYCIN (0.5%)OPHTHALMICOINTMENTFalseAT1996-07-18ERYTHROMYCIN
5ANDA064067_001RXERYTHROMYCIN (0.5%)OPHTHALMICOINTMENTFalseAT1994-07-29ERYTHROMYCIN
6NDA050368_001discontinuedERYTHROMYCIN (0.5%)OPHTHALMICOINTMENTFalseILOTYCIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1061ddd20-94a6-4e3c-ba84-1ebd8529eea6 (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile)prescriptionHuman PrescriptionBausch & Lomb IncorporatedAPI MANUFACTURE, MANUFACTURE2013-09-124242080910
21df120f1-778b-4682-9536-2919b782b074 (view SPL)ERYTHROMYCINOPHTHALMICOINTMENT USP STERILEprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2012-05-233812499990136
337fcdb6e-2a9b-464f-9a0e-d3ca323fcb7a (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile)prescriptionHuman PrescriptionH.J. Harkins Company, Inc.MANUFACTURE2012-02-161529590301
43c1a0020-f3aa-49c9-89ff-b5c548494619 (view SPL)ERYTHROMYCINOPHTHALMICOINTMENT USP STERILEprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-07-261687889666
5407ff426-4cca-4b65-b2d3-eb2f078bfa39 (view SPL)apexaErythromycinOphthalmic Ointment USP, 0.5%STERILERx OnlyprescriptionHuman PrescriptionMwiANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-03-231139850605
662896bec-669e-4f20-a1e4-4f99afd35d32 (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5%prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-09-011631870267
787b45f99-a4d1-47e0-bbb6-50ca19c10010 (view SPL)ERYTHROMYCIN OPHTHALMIC OINTMENT USP STERILE RX ONLYprescriptionHuman PrescriptionPaddock Laboratories, Llc2014-06-031005744024
895b15fd3-84e3-4d27-8744-b56af5e265a0 (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5%prescriptionHuman PrescriptionCardinal HealthREPACK2012-04-102551541276
99ac4dcd2-8cac-404d-b651-da74062d30ed (view SPL)ERYTHROMYCINprescriptionHuman PrescriptionDirect Rxrelabel2014-08-191619190090
109b1c6c13-4562-4c8e-a8bb-42493dc5cadb (view SPL)ILOTYCIN ERYTHROMYCIN OPHTHALMIC OINTMENT USPprescriptionHuman PrescriptionFera Pharmaceuticals2010-10-082481020016
11a0353c10-48c9-4d2a-8047-56ea68ace956 (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5%prescriptionHuman PrescriptionAkornANALYSIS, MANUFACTURE, REPACK2010-06-293174780070
12a76acfc7-fcaf-4153-b395-45c7b685178c (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile)prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-061521250538
13b440cf4c-9d56-4044-9895-1e27df124d06 (view SPL)ERYTHROMYCIN ointmentprescriptionHuman PrescriptionStat Rx Usa Llc2011-05-033165900090
14ba4f06c3-ebce-4896-a5cc-59bb5c2cb4e5 (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile)prescriptionHuman PrescriptionCardinal HealthREPACK2014-04-011551547850
15bd51c566-0d6e-4ff0-8593-8cf9f9d38c4e (view SPL)ILOTYCIN (erythromycin) Ophthalmic Ointment USP 0.5% (5 mg/g) STERILE Rx OnlyprescriptionHuman PrescriptionPaddock Laboratories, Llc2014-10-141005744023
16c7a804bc-dac8-47dc-b7a8-8f2d384652f2 (view SPL)ERYTHROMYCINOPHTHALMICOINTMENT USP STERILEprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-08-011548680644
17ca3a5741-fe73-4fc7-a2a3-35da3b111d26 (view SPL)ErythromycinOphthalmic Ointment USP, 0.5%SterileprescriptionHuman PrescriptionHenry Schein Inc.2015-05-132004047191
18d8952bd4-927b-4bdf-8e13-95a08fca2784 (view SPL)ERYTHROMYCIN OPHTHALMIC OINTMENT USP STERILE RX ONLYprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-07-071687889393
19d8b0abac-c32c-4bd0-8247-5c6d6a9fd17f (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-271216950173
20dc3ee55d-114e-44f2-adb2-fb0c24eba732 (view SPL)ERYTHROMYCINOPHTHALMICOINTMENT USP STERILEprescriptionHuman PrescriptionFera Pharmaceuticals2009-08-011481020008
21e12afac1-56e2-4a1f-8604-471c6d4f9092 (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5%prescriptionHuman PrescriptionRemedyrepack Inc.2013-12-311521250800
22e453b459-9aa7-4873-9b62-340a81aa050b (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5%prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-09-221550451350
23ee3d806e-65ce-42e1-b170-7b35bcb7b06a (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-04-021687889328
24f4b57b8a-089e-4bbc-bcc7-3a9b9b600930 (view SPL)ErythromycinOphthalmic Ointment USP, 0.5%SterileprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-03-081174780824
25fbdf6021-f53f-41ce-b765-f9328dbfe467 (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5%prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545691193
26fd185704-9d91-4999-8c87-bd3cb5085e15 (view SPL)Erythromycin Ophthalmic Ointment USP, 0.5%prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-11-123687889203

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