FDA.report

Application 075479

Type
ANDA
Sponsor
HERITAGE PHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL2.5MGNoNo
002ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL5MGNoNo
003ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL10MGNoNo
004ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL20MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0026Enalapril MaleateEnalapril MaleateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0026Enalapril MaleateEnalapril MaleateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0027Enalapril MaleateEnalapril MaleateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0027Enalapril MaleateEnalapril MaleateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0028Enalapril MaleateEnalapril MaleateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0028Enalapril MaleateEnalapril MaleateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0029Enalapril MaleateEnalapril MaleateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0029Enalapril MaleateEnalapril MaleateTeva Pharmaceuticals USA, Inc.ANDACurrent
23155-704Enalapril maleateEnalapril maleateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-704Enalapril maleateEnalapril maleateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-704Enalapril maleateEnalapril maleateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-705Enalapril maleateEnalapril maleateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-705Enalapril maleateEnalapril maleateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-705Enalapril maleateEnalapril maleateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-706Enalapril maleateEnalapril maleateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-707enalapril maleateenalapril maleateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-772Enalapril maleateEnalapril maleateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-773Enalapril maleateEnalapril maleateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
50090-3166Enalapril MaleateEnalapril MaleateA-S Medication SolutionsANDACurrent
53808-0648Enalapril MaleateEnalapril MaleateState of Florida DOH Central PharmacyANDACurrent
53808-0663Enalapril MaleateEnalapril MaleateState of Florida DOH Central PharmacyANDACurrent
53808-0833Enalapril MaleateEnalapril MaleateState of Florida DOH Central PharmacyANDACurrent
68071-3221Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, Inc.ANDACurrent
68645-605Enalapril maleateEnalapril maleateLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-606Enalapril maleateEnalapril maleateLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-607Enalapril maleateEnalapril maleateLegacy Pharmaceutical Packaging, LLCANDACurrent
69043-032Enalapril maleateEnalapril maleateCronus Pharma LLCANDACurrent
69043-033Enalapril maleateEnalapril maleateCronus Pharma LLCANDACurrent
69043-034enalapril maleateenalapril maleateCronus Pharma LLCANDACurrent
69043-035Enalapril maleateEnalapril maleateCronus Pharma LLCANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.Date
309070ORIG12004-06-03
309060ORIG12000-08-22