Home Applications 091323 Application 091323
Type ANDA
Sponsor LUPIN LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 JENCYCLA NORETHINDRONE TABLET;ORAL-28 0.35MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A091323-001 JENCYCLA NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2013-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091323-001 AB2
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 · 41 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 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091323-001 JENCYCLA 0.35MG TABLET / ORAL-28 AB2 2013-03-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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.
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 57297-877 Jencycla norethindrone LUPIN LIMITED ANDA Current 68180-877 Jencycla norethindrone Lupin Pharmaceuticals, Inc. ANDA Current 68180-877 Jencycla norethindrone Lupin Pharmaceuticals, Inc. ANDA Current 68180-877 Jencycla norethindrone Lupin Pharmaceuticals, Inc. ANDA Current 68180-877 Jencycla norethindrone Lupin Pharmaceuticals, Inc. ANDA Current