FDA.reportPublic FDA data

Application 079009

Type
ANDA
Sponsor
HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL1.25MG;250MGNoNo
002GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;500MGNoNo
003GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL5MG;500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-579Glyburide-Metformin HydrochlorideGlyburide-Metformin HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
10544-580Glyburide-Metformin HydrochlorideGlyburide-Metformin HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
23155-233glyburide-metformin hydrochlorideglyburide-metformin hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-233Glyburide-Metformin HydrochlorideGlyburide-Metformin HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-234glyburide-metformin hydrochlorideglyburide-metformin hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-234Glyburide-Metformin HydrochlorideGlyburide-Metformin HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-235glyburide-metformin hydrochlorideglyburide-metformin hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-235Glyburide-Metformin HydrochlorideGlyburide-Metformin HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
55111-695GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE AND METFORMIN HYDROCHLORIDEDr. Reddy's Laboratories LimitedANDACurrent
55111-696GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE AND METFORMIN HYDROCHLORIDEDr. Reddy's Laboratories LimitedANDACurrent
55111-697GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE AND METFORMIN HYDROCHLORIDEDr. Reddy's Laboratories LimitedANDACurrent