Home Applications 090716 Application 090716
Type ANDA
Sponsor NOVAST LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SETLAKIN ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.03MG;0.15MG 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 A090716-001 SETLAKIN ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090716-001 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 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 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 SETLAKIN LEVONORGESTREL AND ETHINYL ESTRADIOL Northstar Rx LLC b7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb 2025-12-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090716 application number: ANDA090716 ndc (product): 16714-366
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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16714-366 SETLAKIN Levonorgestrel and Ethinyl Estradiol Northstar Rx LLC ANDA Current