Acetazolamide Extended Release Oral Capsule

Brand(s)
Diamox
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Barr Laboratories Inc. (2012-08-14)
Oldest Current Product
2000-02-22
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\ACETAZOLAMIDE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\ACETAZOLAMIDE
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\ACETAZOLAMIDE
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\ACETAZOLAMIDE

product(s) by strength(s)

12 hr acetazolamide 500 mg extended release oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005550513NDABarr Laboratories Inc.2000-02-22ACETAZOLAMIDEORALCAPSULE, EXTENDED RELEASENDA012945df0f2293-3a46-4eda-ad28-6e713bb6c3a3

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550120ANDAHeritage Pharmaceuticals Inc.2012-09-24ACETAZOLAMIDEORALCAPSULE, EXTENDED RELEASEANDA090779a0dc2da1-f42f-483a-83de-56ad81b728df
2683820261ANDAZydus Pharmaceuticals (Usa) Inc.2008-12-15ACETAZOLAMIDEORALCAPSULE, EXTENDED RELEASEANDA040904ff46457a-8029-40b0-90c7-9932d7cca4fb

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790050ANDAKaiser Foundations Hospitals2010-02-09ACETAZOLAMIDEORALCAPSULE, EXTENDED RELEASE683820261ANDA04090468e7c7d8-8ba7-402d-830f-ec890efb87e3
2521250070DiamoxNDARemedyrepack Inc.2013-02-21ACETAZOLAMIDEORALCAPSULE, EXTENDED RELEASE512850754NDA012945acbd120b-c517-4acd-9fe9-04d8ae7465dc
3680840401ANDAAmerican Health Packaging2010-04-14ACETAZOLAMIDEORALCAPSULE, EXTENDED RELEASE683820261ANDA040904218bf305-0bd6-4a84-8936-76f88aa894f7

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA040904ACETAZOLAMIDEZYDUS PHARMACEUTICALS USA INC2008-12-10ANDA040904_001
2ANDA090779ACETAZOLAMIDEHERITAGE PHARMACEUTICALS INC2011-07-14ANDA090779_001
3NDA012945DIAMOXTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INCNDA012945_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040904_001RXACETAZOLAMIDE (500MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2008-12-10ACETAZOLAMIDE
2ANDA090779_001RXACETAZOLAMIDE (500MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2011-07-14ACETAZOLAMIDE
3NDA012945_001RXACETAZOLAMIDE (500MG)ORALCAPSULE, EXTENDED RELEASETrueABDIAMOX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1218bf305-0bd6-4a84-8936-76f88aa894f7 (view SPL)Acetazolamide Extended-Release CapsulesprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-10-263680840401
268e7c7d8-8ba7-402d-830f-ec890efb87e3 (view SPL)Acetazolamide Extended-Release CapsulesprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2010-03-221001790050
374e47451-2bc8-496e-88ad-c10002ee8e22 (view SPL)DIAMOX SEQUELS (Acetazolamide Extended-Release Capsules)prescriptionHuman PrescriptionTeva Women'S Health, Inc.2008-07-013512850754
4a0dc2da1-f42f-483a-83de-56ad81b728df (view SPL)Acetazolamide Extended-Release CapsulesprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2014-01-0212231550120
5acbd120b-c517-4acd-9fe9-04d8ae7465dc (view SPL)DIAMOX SEQUELS (Acetazolamide Extended-Release Capsules)prescriptionHuman PrescriptionRemedyrepack Inc.2013-02-212521250070
6df0f2293-3a46-4eda-ad28-6e713bb6c3a3 (view SPL)Acetazolamide Extended-Release CapsulesprescriptionHuman PrescriptionBarr Laboratories Inc.2012-08-143005550513
7ff46457a-8029-40b0-90c7-9932d7cca4fb (view SPL)Acetazolamide Extended-Release CapsulesRx onlyprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.analysis, label, manufacture, pack2015-04-104683820261

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