FDA.reportPublic FDA data

Application 090606

Type
ANDA
Sponsor
OXFORD PHARMS

Application Products#

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

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
A090606-001MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL500MGTABLET / ORAL2010-07-16

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 22:54:322026-06A090606-001MYCOPHENOLATE MOFETIL500MGTABLET / ORAL2010-07-16a50c72e98297…

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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
MYHIBBINMYCOPHENOLATE MOFETILAzurity Pharmaceuticals, Inc.d9af72d6-7b3e-4c08-94b9-1d8b499cb7f92026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
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 MOFETILVistaPharm, LLC175d8b87-e06a-4c9e-b3de-378114b522742026-01-31Boxed 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
mycophenolate mofetilMYCOPHENOLATE MOFETILAvPAKfbbe6521-0e21-5372-e053-6394a90ae5e42026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: mycophenolate mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETIL HYDROCHLORIDEBPI Labs LLC32001417-130d-4c08-8e63-94ba3627ce5f2025-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
Mycophenolate mofetilMYCOPHENOLATE MOFETILHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3ac54299-15cc-4c7a-8831-60c15a859b852025-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate mofetil
generic name: MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.df3ba2e9-00bb-40af-8658-2c5fd2e398ef2025-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MYCOPHENOLATE MOFETIL
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILA-S Medication Solutionsb4170ad9-67f0-42ea-b694-6b80824a607a2025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetilMYCOPHENOLATE MOFETILAmerican Health Packaging8015f042-54fb-4a7a-a10b-6219e1a450c82025-12-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate mofetil
generic name: MYCOPHENOLATE MOFETIL

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
60219-2135mycophenolate mofetilmycophenolate mofetilAmneal Pharmaceuticals NY LLCANDACurrent
60219-2135mycophenolate mofetilmycophenolate mofetilAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24069ORIG2015-07-06