Home Applications 210050 Application 210050
Type ANDA
Sponsor TEVA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG No No 002 EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG No No 003 EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG No No 004 EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG No 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 A210050-001 EVEROLIMUS EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 A210050-002 EVEROLIMUS EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 A210050-003 EVEROLIMUS EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 A210050-004 EVEROLIMUS EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09
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 4 · 156 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 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 141 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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-7766 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7766 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7766 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7766 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7766 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7766 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7767 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7767 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7767 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7767 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7767 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7767 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7768 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7768 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7768 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7768 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7768 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7768 Everolimus Everolimus Teva Pharmaceuticals USA, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 62238 ORIG 2020-03-23