Home Applications 203435 Application 203435
Type ANDA
Sponsor NOVAST LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LERIBANE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.005MG;1MG No No 002 LERIBANE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.0025MG;0.5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203435-001 LERIBANE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 A203435-002 LERIBANE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 86 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 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203435-001 LERIBANE 0.005MG;1MG TABLET / ORAL AB 2016-06-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203435-002 LERIBANE 0.0025MG;0.5MG TABLET / ORAL AB 2016-06-03 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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 75834-129 Norethindrone Acetate and Ethinyl Estradiol Norethindrone Acetate and Ethinyl Estradiol Nivagen Pharmaceuticals, Inc. ANDA Current 75834-130 Norethindrone Acetate and Ethinyl Estradiol Norethindrone Acetate and Ethinyl Estradiol Nivagen Pharmaceuticals, Inc. ANDA Current