Application 213693

Type
ANDA
Sponsor
ASPEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETYLCYSTEINEACETYLCYSTEINEINJECTABLE;INTRAVENOUS6GM/30ML (200MG/ML)NoNo

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
A213693-001ACETYLCYSTEINEACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUSAP2022-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213693-001AP

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 22:54:322026-06A213693-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUSAP2022-02-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213693-001AP1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetylcysteineACETYLCYSTEINEGlenmark Pharmaceuticals Inc., USAf811ddfc-d7c1-4637-ae81-80c38a77cb802026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213693
application number: ANDA213693