Acetic Acid Otic Solution

Brand(s)
Borofair, VoSoL
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hi-Tech Pharmacal Co., Inc. (2010-01-22)
Oldest Current Product
1994-02-25
License(s)
NDA, ANDA
RxNORM
OTIC SOLUTION\ACETIC ACID
FDAOB
OTIC\SOLUTION/DROPS\ACETIC ACID, GLACIAL: ALUMINUM ACETATE\rdfq
OTIC\SOLUTION/DROPS\ACETIC ACID, GLACIAL\rdfq
SPL Active
AURICULAR (OTIC)\SOLUTION/DROPS\ACETIC ACID
AURICULAR (OTIC)\SOLUTION\ACETIC ACID
SPL Moiety
AURICULAR (OTIC)\SOLUTION/DROPS\ACETIC ACID
AURICULAR (OTIC)\SOLUTION\ACETIC ACID

product(s) by strength(s)

acetic acid 20 mg/ml otic solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1503830889NDAHi-Tech Pharmacal Co., Inc.2010-01-22ACETIC ACIDAURICULAR (OTIC)SOLUTIONNDA012179c53fc11e-b177-446e-839d-391e1b2eacff

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006037038ANDAQualitest Pharmaceuticals2005-02-24ACETIC ACIDAURICULAR (OTIC)SOLUTIONANDA0406073a9598f4-b98b-414a-af74-0d2d64f689ee
2242080615ANDABausch & Lomb Incorporated1994-02-25ACETIC ACIDAURICULAR (OTIC)SOLUTION/DROPSANDA040063e56f136e-7ff9-4035-a749-30c6f6a3d4d7

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009043524BorofairANDAMajor1994-02-25ACETIC ACIDAURICULAR (OTIC)SOLUTION/DROPS009043524ANDA040063040850b0-68c0-4160-b3a8-271e7ec4cde9
2216950222NDARebel Distributors Corp2010-01-22ACETIC ACIDAURICULAR (OTIC)SOLUTION503830889NDA012179a8c12387-4b2b-49c2-b9c5-112ffb133950
3545692311NDAA-S Medication Solutions Llc2010-01-22ACETIC ACIDAURICULAR (OTIC)SOLUTION503830889NDA0121797adb0c2b-1175-49a5-94c8-f50e41041fd6
4550451243NDADispensing Solutions, Inc.2010-01-22ACETIC ACIDAURICULAR (OTIC)SOLUTION503830889NDA01217953d97ebe-fdf0-47af-ba93-a4a3327981de

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040063ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATEBAUSCH AND LOMB PHARMACEUTICALS INC1994-02-25ANDA040063_001
2ANDA040166ACETIC ACIDWOCKHARDT EU OPERATIONS (SWISS) AG1996-07-26ANDA040166_001
3ANDA040607ACETIC ACIDVINTAGE PHARMACEUTICALS LLC2005-02-24ANDA040607_001
4ANDA084476DOMEBOROTrueBAYER PHARMACEUTICALS CORPANDA084476_001
5ANDA085493ACETIC ACIDTrueKV PHARMACEUTICAL COANDA085493_001
6ANDA086845ORLEXTrueWARNER CHILCOTT CO LLCANDA086845_001
7ANDA087146ACETASOLTrueACTAVIS MID ATLANTIC LLCANDA087146_001
8ANDA088606BOROFAIRTruePHARMAFAIR INC1985-08-21ANDA088606_001
9ANDA088638ACETIC ACIDTARO PHARMACEUTICALS USA INC1984-09-06ANDA088638_001
10NDA012179VOSOLHI TECH PHARMACAL CO INCNDA012179_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040063_001RXACETIC ACID, GLACIAL (2%), ALUMINUM ACETATE (0.79%)SOLUTION/DROPSTrue1994-02-25ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE
2ANDA040166_001RXACETIC ACID, GLACIAL (2%)SOLUTION/DROPSTrueAT1996-07-26ACETIC ACID
3ANDA040607_001RXACETIC ACID, GLACIAL (2%)SOLUTION/DROPSFalseAT2005-02-24ACETIC ACID
4ANDA084476_001discontinuedALUMINUM ACETATE (0.79%), ACETIC ACID, GLACIAL (2%)SOLUTION/DROPSFalseDOMEBORO
5ANDA085493_001discontinuedACETIC ACID, GLACIAL (2%)SOLUTION/DROPSFalseACETIC ACID
6ANDA086845_001discontinuedACETIC ACID, GLACIAL (2%)SOLUTION/DROPSFalseORLEX
7ANDA087146_001discontinuedACETIC ACID, GLACIAL (2%)SOLUTION/DROPSFalseACETASOL
8ANDA088606_001discontinuedACETIC ACID, GLACIAL (2%), ALUMINUM ACETATE (0.79%)SOLUTION/DROPSFalse1985-08-21BOROFAIR
9ANDA088638_001RXACETIC ACID, GLACIAL (2%)SOLUTION/DROPSFalseAT1984-09-06ACETIC ACID
10NDA012179_001RXACETIC ACID, GLACIAL (2%)SOLUTION/DROPSFalseATVOSOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1040850b0-68c0-4160-b3a8-271e7ec4cde9 (view SPL)Acetic Acid in AqueousAluminum AcetateprescriptionHuman PrescriptionMajor2009-08-311009043524
239de0239-a4f6-45b0-a3cf-c6fba941c08e (view SPL)VSoL Otic Solution(Acetic acid otic solution, USP)prescriptionHuman PrescriptionEcr PharmaceuticalsMANUFACTURE2010-10-141000950202
33a9598f4-b98b-414a-af74-0d2d64f689ee (view SPL)ACETIC ACID OTIC SOLUTION, USPprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-10-015006037038
453d97ebe-fdf0-47af-ba93-a4a3327981de (view SPL)Acetic Acid Otic Solution, USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-07-122550451243
57adb0c2b-1175-49a5-94c8-f50e41041fd6 (view SPL)Acetic Acid Otic Solution, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-10-061545692311
6a8c12387-4b2b-49c2-b9c5-112ffb133950 (view SPL)Acetic Acid Otic Solution, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-131216950222
7c53fc11e-b177-446e-839d-391e1b2eacff (view SPL)Acetic Acid Otic Solution, USPprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.2010-01-223503830889
8e56f136e-7ff9-4035-a749-30c6f6a3d4d7 (view SPL)Acetic Acid 2% in Aqueous Aluminum Acetate Otic SolutionprescriptionHuman PrescriptionBausch & Lomb IncorporatedMANUFACTURE2013-11-046242080615

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