Application 216637

Type
ANDA
Sponsor
FOSUN WANBANG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUMTABLET, DELAYED RELEASE;ORALEQ 180MG BASENoNo
002MYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUMTABLET, DELAYED RELEASE;ORALEQ 360MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216637-001MYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2024-05-29
A216637-002MYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2024-05-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A216637-001AB
A216637-002AB

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 22:54:322026-06A216637-001MYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2024-05-29a50c72e98297…
2026-08-01 22:54:322026-06A216637-002MYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2024-05-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216637-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A216637-002AB1a50c72e98297…

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
Mycophenolic AcidMYCOPHENOLIC ACIDNovugen Pharma (USA) LLC.cbc3e916-09e2-4e6e-9e5e-98375f5e6d412024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216637
application number: ANDA216637