Home Applications 209297 Application 209297
Type ANDA
Sponsor GLENMARK PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HAILEY 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.03MG;1.5MG 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 A209297-001 HAILEY 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209297-001 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 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209297-001 HAILEY 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2018-06-05 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 Hailey 1.5/30 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Glenmark Pharmaceuticals Inc., USA 021df70a-0c37-4237-a2f7-2597ff6d41f5 2026-01-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209297 application number: ANDA209297 ndc (product): 68462-504
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68462-504 Hailey 1.5/30 Norethindrone Acetate and Ethinyl Estradiol Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-504 Hailey 1.5/30 Norethindrone Acetate and Ethinyl Estradiol Glenmark Pharmaceuticals Inc., USA ANDA Current