FDA.reportPublic FDA data

Application 050278

Type
NDA
Sponsor
AVET

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACHROMYCIN VTETRACYCLINE HYDROCHLORIDECAPSULE;ORAL500MGYesYes
003ACHROMYCIN VTETRACYCLINE HYDROCHLORIDECAPSULE;ORAL250MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-017tetracycline hydrochloridetetracycline hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDACurrent
23155-017tetracycline hydrochloridetetracycline hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDACurrent
23155-017Tetracycline HydrochlorideTetracycline HydrochlorideHeritage Pharmaceuticals Inc.NDACurrent
23155-018tetracycline hydrochloridetetracycline hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDACurrent
23155-018tetracycline hydrochloridetetracycline hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDACurrent
23155-018Tetracycline HydrochlorideTetracycline HydrochlorideHeritage Pharmaceuticals Inc.NDACurrent
23155-487Achromycin VTetracycline HClHeritage Pharmaceuticals Inc.NDACurrent
23155-488Achromycin VTetracycline HClHeritage Pharmaceuticals Inc.NDACurrent
42291-798Tetracycline HydrochlorideTetracycline HydrochlorideAvKARE, Inc.NDACurrent
42291-798Tetracycline HydrochlorideTetracycline HydrochlorideAvKARENDACurrent
42291-799Tetracycline HydrochlorideTetracycline HydrochlorideAvKARE, Inc.NDACurrent
42291-799Tetracycline HydrochlorideTetracycline HydrochlorideAvKARENDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81848SUPPL 2025-04-08
81795SUPPL 2025-04-02
17815SUPPL2015-05-12
7722SUPPL2015-04-29