Home Applications 204213 Application 204213
Type ANDA
Sponsor LUPIN LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FYAVOLV ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.0025MG;0.5MG No No 002 FYAVOLV ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.005MG;1MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A204213-001 FYAVOLV ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 A204213-002 FYAVOLV ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG TABLET / ORAL AB 2015-12-10
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 · 84 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 2026-08-18 06:07:40 2026-07 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 Fyavolv NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Lupin Pharmaceuticals, Inc. 772c86d7-10a4-48c5-8c19-f8aac68f5ab4 2026-01-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204213 application number: ANDA204213 ndc (product): 68180-828 ndc (product): 68180-827
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68180-827 Fyavolv Norethindrone Acetate and Ethinyl Estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-827 Fyavolv Norethindrone Acetate and Ethinyl Estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-827 Fyavolv Norethindrone Acetate and Ethinyl Estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-827 Fyavolv Norethindrone Acetate and Ethinyl Estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-827 Fyavolv Norethindrone Acetate and Ethinyl Estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-828 Fyavolv Norethindrone Acetate and Ethinyl Estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-828 Fyavolv Norethindrone Acetate and Ethinyl Estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-828 Fyavolv Norethindrone Acetate and Ethinyl Estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-828 Fyavolv Norethindrone Acetate and Ethinyl Estradiol Lupin Pharmaceuticals, Inc. ANDA Current 68180-828 Fyavolv Norethindrone Acetate and Ethinyl Estradiol Lupin Pharmaceuticals, Inc. ANDA Current