Home Applications 210030 Application 210030
Type ANDA
Sponsor HETERO LABS LTD V Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 5MG No No 002 TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 20MG No No 003 TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 100MG No No 004 TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 140MG No No 005 TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 180MG No No 006 TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE;ORAL 250MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210030-001 TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 A210030-002 TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 A210030-003 TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 A210030-004 TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 A210030-005 TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 A210030-006 TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 2 · 72 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 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210030-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210030-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210030-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210030-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210030-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210030-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210030-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210030-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210030-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210030-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210030-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210030-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 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.