FDA.reportPublic FDA data

Application 050207

Type
NDA
Sponsor
ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001E.E.S.ERYTHROMYCIN ETHYLSUCCINATEGRANULE;ORALEQ 200MG BASE/5MLYesNo
002ERYPEDERYTHROMYCIN ETHYLSUCCINATEGRANULE;ORALEQ 400MG BASE/5MLYesYes
003ERYPEDERYTHROMYCIN ETHYLSUCCINATEGRANULE;ORALEQ 200MG BASE/5MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24338-130Ery-PedErythromycin EthylsuccinateArbor Pharmaceuticals, Inc.NDACurrent
24338-130Ery-PedErythromycin EthylsuccinateArbor Pharmaceuticals, Inc.NDACurrent
24338-130Ery-PedErythromycin EthylsuccinateAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)NDACurrent
24338-132Ery-PedErythromycin EthylsuccinateAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)NDACurrent
24338-132Ery-PedErythromycin EthylsuccinateArbor Pharmaceuticals, Inc.NDACurrent
24338-132Ery-PedErythromycin EthylsuccinateArbor Pharmaceuticals, Inc.NDACurrent
24338-134E.E.SErythromycin EthylsuccinateArbor Pharmaceuticals, Inc.NDACurrent
24338-134E.E.SErythromycin EthylsuccinateAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)NDACurrent
24338-134E.E.SErythromycin EthylsuccinateArbor Pharmaceuticals, Inc.NDACurrent
24338-134E.E.SErythromycin EthylsuccinateArbor Pharmaceuticals, Inc.NDACurrent
24338-134E.E.SErythromycin EthylsuccinateArbor Pharmaceuticals, Inc.NDACurrent
24338-136E.E.SErythromycin EthylsuccinateArbor Pharmaceuticals, Inc.NDACurrent
24338-136E.E.SErythromycin EthylsuccinateArbor Pharmaceuticals, Inc.NDACurrent
24338-136E.E.SErythromycin EthylsuccinateArbor Pharmaceuticals, Inc.NDACurrent
24338-136E.E.SErythromycin EthylsuccinateArbor Pharmaceuticals, Inc.NDACurrent
24338-136E.E.SErythromycin EthylsuccinateAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)NDACurrent
52536-130ERYTHROMYCIN ETHYLSUCCINATEErythromycin EthylsuccinateWilshire PharmaceuticalsNDACurrent
52536-130ERYTHROMYCIN ETHYLSUCCINATEErythromycin EthylsuccinateWilshire PharmaceuticalsNDACurrent
52536-132ERYTHROMYCIN ETHYLSUCCINATEErythromycin EthylsuccinateWilshire PharmaceuticalsNDACurrent
52536-134Erythromycin EthylsuccinateErythromycin EthylsuccinateWilshire Pharmaceuticals Inc.NDACurrent
52536-136Erythromycin EthylsuccinateErythromycin EthylsuccinateWilshire Pharmaceuticals Inc.NDACurrent
63629-2500Erythromycin EthylsuccinateErythromycin EthylsuccinateBryant Ranch PrepackNDACurrent
63629-2500Erythromycin EthylsuccinateErythromycin EthylsuccinateBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53809SUPPL2018-04-24
53802SUPPL2018-04-24
49497SUPPL2017-08-22
49494SUPPL2017-08-21
17812SUPPL2012-02-06
7717SUPPL2012-02-06
7714SUPPL2011-02-07
17810SUPPL2011-01-31
29996SUPPL2010-11-08
17811SUPPL2009-01-02
7716SUPPL2008-12-19
7715SUPPL2008-05-28
29995SUPPL2008-01-09
38923SUPPL2008-01-08
7712SUPPL2006-08-14
17809SUPPL2006-08-11
42639SUPPL2004-09-21
22154SUPPL2004-09-21
7713SUPPL2004-03-16
7711SUPPL2002-04-25