Lactate Topical Cream

Brand(s)
Geri-Hydrolac, Lac-Hydrin
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Perrigo New York Inc (2015-08-12)
Oldest Current Product
2003-04-10
License(s)
ANDA, EXPORT ONLY, OTC MONOGRAPH NOT FINAL, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
TOPICAL CREAM\LACTATE
FDAOB
TOPICAL\CREAM\AMMONIUM LACTATE
SPL Active
TOPICAL\CREAM\AMMONIUM LACTATE
TOPICAL\CREAM\LACTIC ACID, UNSPECIFIED FORM
SPL Moiety
TOPICAL\CREAM\LACTIC ACID, UNSPECIFIED FORM

product(s) by strength(s)

lactic acid 100 mg/ml topical cream

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1589800915UNAPPROVED DRUG OTHER MARKETING CATEGORYStratus Pharmaceuticals2009-01-16LACTIC ACID, UNSPECIFIED FORMTOPICALCREAM704aa3e3-c2f0-49d9-9ada-f65efde61aae

ammonium lactate 120 mg/ml topical cream

export only product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1541620012Geri-HydrolacEXPORT ONLYGeritrex Corp2013-06-25AMMONIUM LACTATETOPICALCREAMf1be69b8-8cfd-428c-aa79-eeb87e3cd3e3

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1630440404OTC MONOGRAPH NOT FINALNnodum Pharmaceuticals2007-12-30AMMONIUM LACTATETOPICALCREAM34d21510-062e-40ab-b074-ae3a0dc65e68

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005912157ANDAWatson Laboratories, Inc.2012-06-05AMMONIUM LACTATETOPICALCREAMANDA075774787c51de-b303-4084-b685-8fe48d93fa9e
2458020493ANDAPerrigo New York Inc2006-08-16AMMONIUM LACTATETOPICALCREAMANDA0757747096d38e-2bd1-4374-9bf6-7fd09ef7509c
3516721301ANDATaro Pharmaceuticals U.S.A., Inc.2003-04-10AMMONIUM LACTATETOPICALCREAMANDA0758839745b6ce-f532-4e80-b6e9-477ab9db4e30

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA075774AMMONIUM LACTATEPERRIGO NEW YORK INC2002-05-01ANDA075774_001
2ANDA075883AMMONIUM LACTATETARO PHARMACEUTICALS USA INC2003-04-10ANDA075883_001
3ANDA076829AMMONIUM LACTATEWATSON LABORATORIES INC2006-02-07ANDA076829_001
4NDA020508LAC-HYDRINRANBAXY LABORATORIES INC1996-08-29NDA020508_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075774_001RXAMMONIUM LACTATE (EQ 12% BASE)TOPICALCREAMFalseAB2002-05-01AMMONIUM LACTATE
2ANDA075883_001RXAMMONIUM LACTATE (EQ 12% BASE)TOPICALCREAMFalseAB2003-04-10AMMONIUM LACTATE
3ANDA076829_001RXAMMONIUM LACTATE (EQ 12% BASE)TOPICALCREAMFalseAB2006-02-07AMMONIUM LACTATE
4NDA020508_001RXAMMONIUM LACTATE (EQ 12% BASE)TOPICALCREAMTrueAB1996-08-29LAC-HYDRIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
134d21510-062e-40ab-b074-ae3a0dc65e68 (view SPL)Ammonium Lactate CreamotcHuman OTCNnodum PharmaceuticalsMANUFACTURE2009-12-302630440404
2704aa3e3-c2f0-49d9-9ada-f65efde61aae (view SPL)LACTIC ACID 10% E CREAMprescriptionHuman PrescriptionStratus PharmaceuticalsMANUFACTURE2009-10-271589800915
37096d38e-2bd1-4374-9bf6-7fd09ef7509c (view SPL)Ammonium Lactate Cream, 12%*prescriptionHuman PrescriptionPerrigo New York Inc2015-08-126458020493
4787c51de-b303-4084-b685-8fe48d93fa9e (view SPL)Ammonium Lactate Cream, 12%*prescriptionHuman PrescriptionWatson Laboratories, Inc.MANUFACTURE2012-06-113005912157
5807054c6-2dae-4cc2-b790-674ab66cf79b (view SPL)Rx onlyLac-Hydrin 12%*(ammonium lactate) CreamFor Dermatologic use only. Not for Ophthalmic, Oral or Intravaginal use.prescriptionHuman PrescriptionRanbaxy Laboratories Incmanufacture2009-09-251106310099
69745b6ce-f532-4e80-b6e9-477ab9db4e30 (view SPL)Ammonium Lactate Cream 12%*prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-06-123516721301
7f1be69b8-8cfd-428c-aa79-eeb87e3cd3e3 (view SPL)Geri-Hydrolac 12CreamotcHuman OTCGeritrex Corpmanufacture2013-06-251541620012

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