Acetic Acid / Hydrocortisone Otic Solution

Brand(s)
Acetasol HC
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hi-Tech Pharmacal Co., Inc. (2012-08-28)
Oldest Current Product
2002-09-10
License(s)
NDA, ANDA
RxNORM
OTIC SOLUTION\ACETIC ACID:HYDROCORTISONE
FDAOB
OTIC\SOLUTION/DROPS\ACETIC ACID, GLACIAL: HYDROCORTISONE\rdfq
SPL Active
AURICULAR (OTIC)\SOLUTION\ACETIC ACID: HYDROCORTISONE
SPL Moiety
AURICULAR (OTIC)\SOLUTION\ACETIC ACID: HYDROCORTISONE

product(s) by strength(s)

acetic acid 20 mg/ml / hydrocortisone 10 mg/ml otic solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1503830901NDAHi-Tech Pharmacal Co., Inc.2009-06-04ACETIC ACID, HYDROCORTISONEAURICULAR (OTIC)SOLUTIONNDA012770ffd1edc1-2f40-4b0a-a53a-9fb53b8d3184

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004720882Acetasol HCANDAActavis Pharma, Inc.2002-09-10ACETIC ACID, HYDROCORTISONEAURICULAR (OTIC)SOLUTIONANDA087143a89b7168-e363-4303-b517-de4b9eb0f857
2006037039ANDAQualitest Pharmaceuticals2006-02-06ACETIC ACID, HYDROCORTISONEAURICULAR (OTIC)SOLUTIONANDA040609adfc6013-ec78-4225-b88b-2b4aa9fd8e1f
3459630412ANDAActavis Inc.2009-06-29ACETIC ACID, HYDROCORTISONEAURICULAR (OTIC)SOLUTIONANDA087143854f3663-35e4-4aef-9dfa-7e023b70b8fd
4516723007ANDATaro Pharmaceuticals U.S.A., Inc.2005-04-28ACETIC ACID, HYDROCORTISONEAURICULAR (OTIC)SOLUTIONANDA0887596383c722-84e2-4719-a13d-19c54e3eefff

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040097HYDROCORTISONE AND ACETIC ACIDTrueBAUSCH AND LOMB PHARMACEUTICALS INC1994-10-31ANDA040097_001
2ANDA040168HYDROCORTISONE AND ACETIC ACIDTrueWOCKHARDT EU OPERATIONS (SWISS) AG1996-08-30ANDA040168_001
3ANDA040609HYDROCORTISONE AND ACETIC ACIDVINTAGE PHARMACEUTICALS LLC2006-02-06ANDA040609_001
4ANDA085492ACETIC ACID W/ HYDROCORTISONETrueKV PHARMACEUTICAL COANDA085492_001
5ANDA086844ORLEX HCTrueWARNER CHILCOTT CO LLCANDA086844_001
6ANDA087143ACETASOL HCACTAVIS MID ATLANTIC LLC1982-01-13ANDA087143_001
7ANDA088759HYDROCORTISONE AND ACETIC ACIDTARO PHARMACEUTICALS USA INC1985-03-04ANDA088759_001
8NDA012770VOSOL HCHI TECH PHARMACAL CO INCNDA012770_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040097_001discontinuedACETIC ACID, GLACIAL (2%), HYDROCORTISONE (1%)SOLUTION/DROPSFalse1994-10-31HYDROCORTISONE AND ACETIC ACID
2ANDA040168_001discontinuedACETIC ACID, GLACIAL (2%), HYDROCORTISONE (1%)SOLUTION/DROPSFalse1996-08-30HYDROCORTISONE AND ACETIC ACID
3ANDA040609_001RXACETIC ACID, GLACIAL (2%), HYDROCORTISONE (1%)SOLUTION/DROPSFalseAT2006-02-06HYDROCORTISONE AND ACETIC ACID
4ANDA085492_001discontinuedHYDROCORTISONE (1%), ACETIC ACID, GLACIAL (2%)SOLUTION/DROPSFalseACETIC ACID W/ HYDROCORTISONE
5ANDA086844_001discontinuedACETIC ACID, GLACIAL (2%), HYDROCORTISONE (1%)SOLUTION/DROPSFalseORLEX HC
6ANDA087143_001RXACETIC ACID, GLACIAL (2%), HYDROCORTISONE (1%)SOLUTION/DROPSFalseAT1982-01-13ACETASOL HC
7ANDA088759_001RXACETIC ACID, GLACIAL (2%), HYDROCORTISONE (1%)SOLUTION/DROPSFalseAT1985-03-04HYDROCORTISONE AND ACETIC ACID
8NDA012770_001RXHYDROCORTISONE (1%), ACETIC ACID, GLACIAL (2%)SOLUTION/DROPSTrueATVOSOL HC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
16383c722-84e2-4719-a13d-19c54e3eefff (view SPL)Hydrocortisone 1% and Acetic Acid 2% Otic SolutionprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-06-122516723007
2854f3663-35e4-4aef-9dfa-7e023b70b8fd (view SPL)HYDROCORTISONE AND ACETIC ACID OTIC SOLUTION USPprescriptionHuman PrescriptionActavis Inc.2009-09-153459630412
3a89b7168-e363-4303-b517-de4b9eb0f857 (view SPL)HYDROCORTISONE AND ACETIC ACID OTIC SOLUTION USP FORM 0882 VC3300 Rev. 3/08prescriptionHuman PrescriptionActavis Pharma, Inc.2009-04-092004720882
4adfc6013-ec78-4225-b88b-2b4aa9fd8e1f (view SPL)HYDROCORTISONE AND ACETIC ACID OTIC SOLUTION, USP Rx onlyprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2009-09-153006037039
5ffd1edc1-2f40-4b0a-a53a-9fb53b8d3184 (view SPL)Hydrocortisone and Acetic Acid Otic Solution, USPprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.2012-08-283503830901

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