Home Applications 021098 Application 021098
Type NDA
Sponsor BAYER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 YASMIN DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Yes Yes
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 N021098-001 YASMIN DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021098-001 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 · 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 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021098-001 6787531 2020-08-31 Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021098-001 6787531 2020-08-31 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021098-001 6787531 2020-08-31 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021098-001 6787531 2020-08-31 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021098-001 6787531 2020-08-31 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021098-001 6787531 2020-08-31 Drug product ea99ee380514…
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 Yasmin DROSPIRENONE AND ETHINYL ESTRADIOL Bayer HealthCare Pharmaceuticals Inc. d7ea6a60-5a56-4f81-b206-9b27b7e58875 2023-05-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021098 application number: NDA021098 ndc (product): 50419-402
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0555-9131 OCELLA drospirenone and ethinyl estradiol TEVA PHARMACEUTICALS USA, INC. NDA AUTHORIZED GENERIC Current 0555-9131 OCELLA drospirenone and ethinyl estradiol TEVA PHARMACEUTICALS USA, INC. NDA AUTHORIZED GENERIC Current 0555-9131 OCELLA drospirenone and ethinyl estradiol TEVA PHARMACEUTICALS USA, INC. NDA AUTHORIZED GENERIC Current 0555-9131 OCELLA drospirenone and ethinyl estradiol TEVA PHARMACEUTICALS USA, INC. NDA AUTHORIZED GENERIC Current 0555-9131 OCELLA drospirenone and ethinyl estradiol TEVA PHARMACEUTICALS USA, INC. NDA AUTHORIZED GENERIC Current 0555-9131 OCELLA drospirenone and ethinyl estradiol TEVA PHARMACEUTICALS USA, INC. NDA AUTHORIZED GENERIC Current 0555-9131 OCELLA drospirenone and ethinyl estradiol TEVA PHARMACEUTICALS USA, INC. NDA AUTHORIZED GENERIC Current 0555-9131 OCELLA drospirenone and ethinyl estradiol TEVA PHARMACEUTICALS USA, INC. NDA AUTHORIZED GENERIC Current 50419-402 Yasmin drospirenone and ethinyl estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-402 Yasmin drospirenone and ethinyl estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-402 Yasmin drospirenone and ethinyl estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-402 Yasmin drospirenone and ethinyl estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-402 Yasmin drospirenone and ethinyl estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 76413-130 Yasmin drospirenone and ethinyl estradiol Central Texas Community Health Centers NDA Current