Home Applications 021560 Application 021560
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZORTRESS EVEROLIMUS TABLET;ORAL 0.25MG Yes No 002 ZORTRESS EVEROLIMUS TABLET;ORAL 0.5MG Yes No 003 ZORTRESS EVEROLIMUS TABLET;ORAL 0.75MG Yes Yes 004 ZORTRESS EVEROLIMUS TABLET;ORAL 1MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021560-001 ZORTRESS EVEROLIMUS 0.25MG TABLET / ORAL AB RLD 2010-04-20 N021560-002 ZORTRESS EVEROLIMUS 0.5MG TABLET / ORAL AB RLD 2010-04-20 N021560-003 ZORTRESS EVEROLIMUS 0.75MG TABLET / ORAL AB RLD 2010-04-20 N021560-004 ZORTRESS EVEROLIMUS 1MG TABLET / ORAL AB RLD 2018-08-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 168 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 2026-08-18 06:07:40 2026-07 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD 2018-08-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021560-001 5665772 2019-09-09 U-1049 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-001 5665772 2019-09-09 U-1365 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-001 5665772*PED 2020-03-09 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-002 5665772 2019-09-09 U-1049 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-002 5665772 2019-09-09 U-1365 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-002 5665772*PED 2020-03-09 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-003 5665772 2019-09-09 U-1365 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-003 5665772 2019-09-09 U-1049 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-003 5665772*PED 2020-03-09 Pediatric extension 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021560-001 5665772*PED 2020-03-09 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021560-002 5665772*PED 2020-03-09 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021560-003 5665772*PED 2020-03-09 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021560-001 5665772*PED 2020-03-09 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021560-002 5665772*PED 2020-03-09 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021560-003 5665772*PED 2020-03-09 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021560-001 5665772 2019-09-09 U-1049 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-001 5665772 2019-09-09 U-1365 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-001 5665772*PED 2020-03-09 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-002 5665772 2019-09-09 U-1049 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-002 5665772 2019-09-09 U-1365 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-002 5665772*PED 2020-03-09 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-003 5665772 2019-09-09 U-1365 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-003 5665772 2019-09-09 U-1049 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-003 5665772*PED 2020-03-09 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021560-001 5665772 2019-09-09 U-1049 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-001 5665772 2019-09-09 U-1365 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-001 5665772*PED 2020-03-09 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-002 5665772 2019-09-09 U-1049 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-002 5665772 2019-09-09 U-1365 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-002 5665772*PED 2020-03-09 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-003 5665772 2019-09-09 U-1365 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-003 5665772 2019-09-09 U-1049 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-003 5665772*PED 2020-03-09 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021560-001 5665772 2019-09-09 U-1365 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021560-001 5665772 2019-09-09 U-1049 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021560-001 5665772*PED 2020-03-09 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021560-002 5665772 2019-09-09 U-1365 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021560-002 5665772 2019-09-09 U-1049 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021560-002 5665772*PED 2020-03-09 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021560-003 5665772 2019-09-09 U-1365 Drug substance, Drug product ea99ee380514…
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 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0414 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0414 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0414 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0414 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0414 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0414 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0415 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0415 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0415 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0415 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0415 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0415 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0417 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0417 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0417 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0417 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0417 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0417 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0422 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0422 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0422 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0422 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0422 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current 0078-0422 Zortress everolimus Novartis Pharmaceuticals Corporation NDA Current