FDA.reportPublic FDA data

Application 078065

Type
ANDA
Sponsor
NORTEC DEV ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL60MGNoNo
002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL80MGNoNo
003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGNoNo
004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL160MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42689-011Propranolol HydrochloridePropranolol HydrochlorideNortec Development Associates, IncANDACurrent
42689-011Propranolol HydrochloridePropranolol HydrochlorideNortec Development Associates, IncANDACurrent
42689-011Propranolol HydrochloridePropranolol HydrochlorideNortec Development Associates, IncANDACurrent
42689-012Propranolol HydrochloridePropranolol HydrochlorideNortec Development Associates, IncANDACurrent
42689-012Propranolol HydrochloridePropranolol HydrochlorideNortec Development Associates, IncANDACurrent
42689-012Propranolol HydrochloridePropranolol HydrochlorideNortec Development Associates, IncANDACurrent
42689-013Propranolol HydrochloridePropranolol HydrochlorideNortec Development Associates, IncANDACurrent
42689-013Propranolol HydrochloridePropranolol HydrochlorideNortec Development Associates, IncANDACurrent
42689-013Propranolol HydrochloridePropranolol HydrochlorideNortec Development Associates, IncANDACurrent
42689-014Propranolol HydrochloridePropranolol HydrochlorideNortec Development Associates, IncANDACurrent
42689-014Propranolol HydrochloridePropranolol HydrochlorideNortec Development Associates, IncANDACurrent
42689-014Propranolol HydrochloridePropranolol HydrochlorideNortec Development Associates, IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39549ORIG2007-01-31
9113ORIG2007-01-31