Home Applications 050715 Application 050715
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NEORAL CYCLOSPORINE CAPSULE;ORAL 25MG Yes No 002 NEORAL CYCLOSPORINE CAPSULE;ORAL 100MG Yes Yes 003 NEORAL CYCLOSPORINE CAPSULE;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N050715-001 NEORAL CYCLOSPORINE 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 N050715-002 NEORAL CYCLOSPORINE 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 N050715-003 NEORAL CYCLOSPORINE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1995-07-14
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 2 of 4 · 132 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 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050715-003 NEORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1995-07-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050715-003 NEORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1995-07-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050715-003 NEORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1995-07-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050715-003 NEORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1995-07-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050715-003 NEORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1995-07-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050715-003 NEORAL 50MG CAPSULE / ORAL RLD 1995-07-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050715-003 NEORAL 50MG CAPSULE / ORAL RLD 1995-07-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050715-003 NEORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE / ORAL RLD 1995-07-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050715-003 NEORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1995-07-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050715-003 NEORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE / ORAL RLD 1995-07-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050715-003 NEORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE / ORAL RLD 1995-07-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050715-003 NEORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE / ORAL RLD 1995-07-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050715-003 NEORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE / ORAL RLD 1995-07-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050715-001 NEORAL 25MG CAPSULE / ORAL AB1 RLD 1995-07-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050715-002 NEORAL 100MG CAPSULE / ORAL AB1 RLD, RS 1995-07-14 c0c555d07b60…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Neoral CYCLOSPORINE Novartis Pharmaceuticals Corporation 94461af3-11f1-4670-95d4-2965b9538ae3 2026-08-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 050715 application number: NDA050715 ndc (product): 0078-0248 ndc (product): 0078-0246
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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0246 Neoral cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0246 Neoral cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0246 Neoral cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0246 Neoral cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0246 Neoral cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0248 Neoral cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0248 Neoral cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0248 Neoral cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0248 Neoral cyclosporine Novartis Pharmaceuticals Corporation NDA Current 0078-0248 Neoral cyclosporine Novartis Pharmaceuticals Corporation NDA Current