Home Applications 021355 Application 021355
Type NDA
Sponsor BAYER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ANGELIQ DROSPIRENONE; ESTRADIOL TABLET;ORAL 0.25MG;0.5MG Yes No 002 ANGELIQ DROSPIRENONE; ESTRADIOL TABLET;ORAL 0.5MG;1MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021355-001 ANGELIQ DROSPIRENONE; ESTRADIOL 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 N021355-002 ANGELIQ DROSPIRENONE; ESTRADIOL 0.5MG;1MG TABLET / ORAL AB RLD, RS 2005-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021355-002 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021355-001 8906890 2031-10-22 Drug product 2015-01-08
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 · 82 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 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL AB RLD, RS 2005-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL AB RLD, RS 2005-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 782e0a99824c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021355-002 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021355-002 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021355-002 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 cb3db0bc1861…
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 Angeliq DROSPIRENONE AND ESTRADIOL Bayer HealthCare Pharmaceuticals Inc. 761834c2-6b61-4583-84c2-f1ca4a97c4f2 2026-03-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021355 application number: NDA021355 ndc (product): 50419-483 ndc (product): 50419-482
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50419-482 Angeliq drospirenone and estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-482 Angeliq drospirenone and estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-482 Angeliq drospirenone and estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-482 Angeliq drospirenone and estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-482 Angeliq drospirenone and estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-482 Angeliq drospirenone and estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-483 Angeliq drospirenone and estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-483 Angeliq drospirenone and estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-483 Angeliq drospirenone and estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-483 Angeliq drospirenone and estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-483 Angeliq drospirenone and estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-483 Angeliq drospirenone and estradiol Bayer HealthCare Pharmaceuticals Inc. NDA Current