FDA.reportPublic FDA data

Application 065477

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILTABLET;ORAL500MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065477-001MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL500MGTABLET / ORAL2009-05-04

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A065477-001MYCOPHENOLATE MOFETIL500MGTABLET / ORAL2009-05-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065477-001MYCOPHENOLATE MOFETIL500MGTABLET / ORAL2009-05-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065477-001MYCOPHENOLATE MOFETIL500MGTABLET / ORAL2009-05-04a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mycophenolate mofetilMYCOPHENOLATE MOFETILREMEDYREPACK INC.84c6f6bb-8924-4da5-9629-126197195f832026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetilMYCOPHENOLATE MOFETILStrides Pharma Inc.9d8c09fc-1df2-4f39-8e1a-c4b296d1a2602026-09-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILTeva Pharmaceuticals USA, Inc.b414303f-e6f3-4e22-a537-96be352b59a42026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetilMYCOPHENOLATE MOFETILAvPAKfbbe6521-0e21-5372-e053-6394a90ae5e42026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: mycophenolate mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILAmneal Pharmaceuticals LLC27fd9381-8d82-4187-897f-98f41f94e90f2026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILA-S Medication Solutionsb4170ad9-67f0-42ea-b694-6b80824a607a2026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILQUAGEN PHARMACEUTICALS LLC838449b3-4397-4e35-b9b9-683f5a48bff22026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
generic name: MYCOPHENOLATE MOFETIL
CellCeptMYCOPHENOLATE MOFETILGenentech, Inc.37241e87-4af4-4dc3-a1aa-ea6f20d8dc402026-08-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetilMYCOPHENOLATE MOFETILMajor Pharmaceuticals6abc5727-ee8e-43ad-ab39-0eef2feb257a2026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: mycophenolate mofetil
generic name: MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILREMEDYREPACK INC.d203775c-bf36-460c-bacf-3ab2348a514f2026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MYCOPHENOLATE MOFETIL
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetilMYCOPHENOLATE MOFETILREMEDYREPACK INC.77a75d5b-a90d-4ee5-aa8a-6da97d1303572026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetilMYCOPHENOLATE MOFETILAscend Laboratories, LLC21ff53b0-b4ba-4473-91e4-76ef416810642026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate mofetil
generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetilMYCOPHENOLATE MOFETILBryant Ranch Prepack0f1704e2-a66a-4be5-8127-ebb5947c7b642026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: mycophenolate mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILPar Health USA, LLC35ba0428-e267-49a5-99a9-c58853f7989d2026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetilMYCOPHENOLATE MOFETILAccord Healthcare Inc.741e079a-646b-47ec-84ac-8e12574c2aaf2026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: mycophenolate mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILMeitheal Pharmaceuticals Inc.9650af9b-d36f-4a2f-9647-d0f7989334022026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILAscend Laboratories, LLC9f84ea84-2d8b-4d91-a33f-7dfb5df937dc2026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetilMYCOPHENOLATE MOFETILMajor Pharmaceuticalsd176199c-dc3f-48c8-b7d2-c5d0a6a242fe2026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILCamber Pharmaceuticals, Inc.c3ded171-89da-4644-9ee8-dbcf6258036f2026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
generic name: MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILNorthStar Rx LLC127eabe2-8386-452a-ad6b-d879e1f2c0992026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MYCOPHENOLATE MOFETIL
generic name: MYCOPHENOLATE MOFETIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-681Mycophenolate MofetilMycophenolate MofetilCadila Healthcare LimitedANDACurrent
68382-131Mycophenolate MofetilMycophenolate MofetilZydus Pharmaceuticals (USA) Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44243ORIG2009-07-15