Home Applications 206238 Application 206238
Type ANDA
Sponsor SUNSHINE LAKE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OLANZAPINE OLANZAPINE TABLET;ORAL 2.5MG No No 002 OLANZAPINE OLANZAPINE TABLET;ORAL 5MG No No 003 OLANZAPINE OLANZAPINE TABLET;ORAL 7.5MG No No 004 OLANZAPINE OLANZAPINE TABLET;ORAL 10MG No No 005 OLANZAPINE OLANZAPINE TABLET;ORAL 15MG No No 006 OLANZAPINE OLANZAPINE TABLET;ORAL 20MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A206238-001 OLANZAPINE OLANZAPINE 2.5MG TABLET / ORAL AB 2018-11-19 A206238-002 OLANZAPINE OLANZAPINE 5MG TABLET / ORAL AB 2018-11-19 A206238-003 OLANZAPINE OLANZAPINE 7.5MG TABLET / ORAL AB 2018-11-19 A206238-004 OLANZAPINE OLANZAPINE 10MG TABLET / ORAL AB 2018-11-19 A206238-005 OLANZAPINE OLANZAPINE 15MG TABLET / ORAL AB 2018-11-19 A206238-006 OLANZAPINE OLANZAPINE 20MG TABLET / ORAL AB 2018-11-19
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 7 · 246 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 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206238-005 OLANZAPINE 15MG TABLET / ORAL 2018-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206238-006 OLANZAPINE 20MG TABLET / ORAL 2018-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206238-005 OLANZAPINE 15MG TABLET / ORAL 2018-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206238-006 OLANZAPINE 20MG TABLET / ORAL 2018-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206238-005 OLANZAPINE 15MG TABLET / ORAL 2018-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206238-006 OLANZAPINE 20MG TABLET / ORAL 2018-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206238-005 OLANZAPINE 15MG TABLET / ORAL 2018-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206238-006 OLANZAPINE 20MG TABLET / ORAL 2018-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206238-005 OLANZAPINE 15MG TABLET / ORAL 2018-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206238-006 OLANZAPINE 20MG TABLET / ORAL 2018-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206238-005 OLANZAPINE 15MG TABLET / ORAL 2018-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206238-006 OLANZAPINE 20MG TABLET / ORAL 2018-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206238-001 OLANZAPINE 2.5MG TABLET / ORAL 2018-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206238-002 OLANZAPINE 5MG TABLET / ORAL 2018-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206238-003 OLANZAPINE 7.5MG TABLET / ORAL 2018-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206238-004 OLANZAPINE 10MG TABLET / ORAL 2018-11-19 2680178bc6a6…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206238-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206238-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206238-003 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206238-004 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206238-005 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206238-006 AB 1 a50c72e98297…
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 OLANZAPINE OLANZAPINE HEC Pharm USA Inc. 4d34f8f3-edc8-0a68-e063-6394a90a9c1f 2026-03-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206238 application number: ANDA206238
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 48792-7824 OLANZAPINE Olanzapine Sunshine Lake Pharma Co., Ltd. ANDA Current 48792-7825 OLANZAPINE Olanzapine Sunshine Lake Pharma Co., Ltd. ANDA Current 48792-7826 OLANZAPINE Olanzapine Sunshine Lake Pharma Co., Ltd. ANDA Current 48792-7827 OLANZAPINE Olanzapine Sunshine Lake Pharma Co., Ltd. ANDA Current 48792-7828 OLANZAPINE Olanzapine Sunshine Lake Pharma Co., Ltd. ANDA Current 48792-7829 OLANZAPINE Olanzapine Sunshine Lake Pharma Co., Ltd. ANDA Current