Home Applications 050625 Application 050625
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SANDIMMUNE CYCLOSPORINE CAPSULE;ORAL 25MG Yes No 002 SANDIMMUNE CYCLOSPORINE CAPSULE;ORAL 100MG Yes Yes 003 SANDIMMUNE CYCLOSPORINE CAPSULE;ORAL 50MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050625-001 SANDIMMUNE CYCLOSPORINE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 N050625-002 SANDIMMUNE CYCLOSPORINE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 N050625-003 SANDIMMUNE CYCLOSPORINE 50MG CAPSULE / ORAL BX RLD 1992-11-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 1 of 4 · 123 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 2026-02-19 14:30 UTC 2026-02 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0240 Sandimmune cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0240 Sandimmune cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0240 Sandimmune cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0240 Sandimmune cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0240 Sandimmune cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0240 Sandimmune cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0241 Sandimmune cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0241 Sandimmune cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0241 Sandimmune cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0241 Sandimmune cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0241 Sandimmune cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0241 Sandimmune cyclosporine Novartis Pharmaceuticals Corporation NDA Current