FDA.reportPublic FDA data

Application 212189

Type
ANDA
Sponsor
AVET LIFESCIENCES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDEINJECTABLE;INJECTION0.2MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212189-001ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONAP2021-11-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A212189-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A212189-001ISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONAP2021-11-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212189-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d140b27a-3bf7-4e0f-bb91-02b588184f522025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212189
application number: ANDA212189
ndc (product): 23155-661
ndc (product): 23155-660
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEAvenacy, Inc.212af0f4-42c7-425d-8baf-9a2f594289a22024-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212189
application number: ANDA212189

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-660Isoproterenol HydrochlorideIsoproterenol HydrochlorideHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.ANDACurrent
23155-660Isoproterenol HydrochlorideIsoproterenol HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-660Isoproterenol HydrochlorideIsoproterenol HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-660Isoproterenol HydrochlorideIsoproterenol HydrochlorideHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.ANDACurrent
23155-661Isoproterenol HydrochlorideIsoproterenol HydrochlorideHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.ANDACurrent
23155-661Isoproterenol HydrochlorideIsoproterenol HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-661Isoproterenol HydrochlorideIsoproterenol HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-661Isoproterenol HydrochlorideIsoproterenol HydrochlorideHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.ANDACurrent
70860-306Isoproterenol Hydrochlorideisoproterenol hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent