FDA.reportPublic FDA data

Application 214376

Type
ANDA
Sponsor
AMTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCOPHENOLIC ACIDMYCOPHENOLIC ACIDTABLET, DELAYED RELEASE;ORAL180MGNoNo
002MYCOPHENOLIC ACIDMYCOPHENOLIC ACIDTABLET, DELAYED RELEASE;ORAL360MGNoNo

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
A214376-001MYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2021-02-10
A214376-002MYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2021-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214376-001AB
A214376-002AB

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 22:54:322026-06A214376-001MYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2021-02-10a50c72e98297…
2026-08-01 22:54:322026-06A214376-002MYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2021-02-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214376-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A214376-002AB1a50c72e98297…

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 ACIDSlate Run Pharmaceuticals, LLCc1ce92ef-4102-1487-e053-2995a90ac5212026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214376
application number: ANDA214376
ndc (product): 70436-172
ndc (product): 70436-173

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70436-172Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-172Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-172Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-172Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-173Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-173Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-173Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-173Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
72322-1048Mycophenolic AcidMycophenolic AcidAMTA LABS LIMITEDANDACurrent
72322-1049Mycophenolic AcidMycophenolic AcidAMTA LABS LIMITEDANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76498ORIG 2023-11-07