Home Applications 206852 Application 206852
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LO SIMPESSE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.02MG,0.1MG;0.01MG,N/A No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206852-001 LO SIMPESSE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206852-001 AB
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 · 43 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 2026-09-14 22:38:34 2026-08 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 Lo Simpesse LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Aurobindo Pharma Limited 74d998ca-7b30-4023-928f-a0f0551992e6 2023-05-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206852 application number: ANDA206852 ndc (product): 65862-866
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65862-866 Lo Simpesse Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol Aurobindo Pharma Limited ANDA Current 65862-866 Lo Simpesse Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol Aurobindo Pharma Limited ANDA Current 65862-866 Lo Simpesse Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol Aurobindo Pharma Limited ANDA Current 65862-866 Lo Simpesse Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol Aurobindo Pharma Limited ANDA Current 65862-866 Lo Simpesse Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol Aurobindo Pharma Limited ANDA Current