Home Applications 050791 Application 050791
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MYFORTIC MYCOPHENOLIC ACID TABLET, DELAYED RELEASE;ORAL 180MG Yes No 002 MYFORTIC MYCOPHENOLIC ACID TABLET, DELAYED RELEASE;ORAL 360MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050791-001 MYFORTIC MYCOPHENOLATE SODIUM EQ 180MG BASE TABLET, DELAYED RELEASE / ORAL AB RLD 2004-02-27 N050791-002 MYFORTIC MYCOPHENOLATE SODIUM EQ 360MG BASE TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2004-02-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N050791-001 MYFORTIC EQ 180MG BASE TABLET, DELAYED RELEASE / ORAL AB RLD 2004-02-27 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050791-002 MYFORTIC EQ 360MG BASE TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2004-02-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050791-001 MYFORTIC EQ 180MG BASE TABLET, DELAYED RELEASE / ORAL AB RLD 2004-02-27 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050791-002 MYFORTIC EQ 360MG BASE TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2004-02-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050791-001 MYFORTIC EQ 180MG BASE TABLET, DELAYED RELEASE / ORAL AB RLD 2004-02-27 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050791-002 MYFORTIC EQ 360MG BASE TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2004-02-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050791-001 MYFORTIC EQ 180MG BASE TABLET, DELAYED RELEASE / ORAL AB RLD 2004-02-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050791-002 MYFORTIC EQ 360MG BASE TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2004-02-27 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
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 1 · 1 matching rows.
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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0385 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0385 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0385 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0385 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0385 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0385 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0385 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0386 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0386 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0386 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0386 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0386 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0386 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current 0078-0386 Myfortic mycophenolic acid Novartis Pharmaceuticals Corporation NDA Current