Home Applications 021676 Application 021676
Type NDA
Sponsor BAYER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 YAZ DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG 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 N021676-001 YAZ DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021676-001 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 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021676-001 YAZ 3MG;0.02MG TABLET / ORAL AB RLD, RS 2006-03-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# 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 Yaz DROSPIRENONE AND ETHINYL ESTRADIOL Bayer HealthCare Pharmaceuticals Inc. 065f33e4-b587-4e66-b896-ca9ab7b7c876 2025-05-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021676 application number: NDA021676 ndc (product): 50419-405
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-5423 Gianvi Drospirenone and ethinyl estradiol Teva Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-5423 Gianvi Drospirenone and ethinyl estradiol Teva Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-5423 Gianvi Drospirenone and ethinyl estradiol Teva Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-5423 Gianvi Drospirenone and ethinyl estradiol Teva Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-5423 Gianvi Drospirenone and ethinyl estradiol Teva Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-5423 Gianvi Drospirenone and ethinyl estradiol Teva Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-5423 Gianvi Drospirenone and ethinyl estradiol Teva Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-5423 Gianvi Drospirenone and ethinyl estradiol Teva Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 0093-5423 Gianvi Drospirenone and ethinyl estradiol Teva Pharmaceuticals USA Inc NDA AUTHORIZED GENERIC Current 50419-405 Yaz Drospirenone and ethinyl estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-405 Yaz Drospirenone and ethinyl estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-405 Yaz Drospirenone and ethinyl estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-405 Yaz Drospirenone and ethinyl estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-405 Yaz Drospirenone and ethinyl estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-405 Yaz Drospirenone and ethinyl estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 66116-470 Gianvi Drospirenone and ethinyl estradiol MedVantx, Inc. NDA Current