Home Applications 090538 Application 090538
Type ANDA
Sponsor GLENMARK GENERICS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BRIELLYN ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG;0.4MG 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 A090538-001 BRIELLYN ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090538-001 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 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090538-001 BRIELLYN 0.035MG;0.4MG TABLET / ORAL-28 AB 2011-03-22 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 BRIELLYN NORETHINDRONE AND ETHINYL ESTRADIOL Glenmark Pharmaceuticals Inc., USA c0e2c5b4-70ac-4b41-aa71-00e506dbb72f 2026-01-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090538 application number: ANDA090538 ndc (product): 68462-316
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 68462-316 BRIELLYN Norethindrone and Ethinyl Estradiol Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-316 BRIELLYN Norethindrone and Ethinyl Estradiol Glenmark Pharmaceuticals Inc., USA ANDA Current