Application 022574

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SAFYRAL	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	TABLET;ORAL	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N022574-001	SAFYRAL	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-12-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022574-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022574-001	8617597	2030-02-08		Drug product	2014-01-29
N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15
N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15

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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	N022574-001	SAFYRAL	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022574-001	SAFYRAL	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022574-001	SAFYRAL	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-12-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022574-001	SAFYRAL	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-12-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N022574-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022574-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022574-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022574-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022574-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022574-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022574-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022574-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022574-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022574-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022574-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022574-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022574-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022574-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022574-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022574-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022574-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022574-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022574-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022574-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022574-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022574-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022574-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022574-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022574-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022574-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022574-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022574-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022574-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022574-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022574-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022574-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022574-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022574-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022574-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022574-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022574-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022574-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022574-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022574-001	AB	1	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 127 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022574-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022574-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022574-001	8617597	2030-02-08		Drug product	2014-01-29	`79d66fd596c7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM	Sandoz Inc	6928f186-190d-4c40-beab-81cf80cd45cb	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022574 application number: NDA022574 ndc (product): 0781-4103
Safyral	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM	Bayer HealthCare Pharmaceuticals Inc.	97563516-306a-4e17-9690-edbda49ecd83	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022574 application number: NDA022574 ndc (product): 50419-403

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74342	SUPPL	2023-05-22
74330	SUPPL	2023-05-22
70945	SUPPL	2022-05-03
70900	SUPPL	2022-05-02
49384	SUPPL	2017-08-15
49297	SUPPL	2017-08-09
42563	SUPPL	2016-02-03
22062	SUPPL	2016-02-03
17730	SUPPL	2015-06-04
7559	SUPPL	2015-06-03
29875	SUPPL	2012-04-12
17729	SUPPL	2012-04-10
7558	SUPPL	2012-02-21
17728	SUPPL	2012-02-14
23714	ORIG	2011-11-16
44782	ORIG	2011-07-15
42562	ORIG	2011-07-15
38857	ORIG	2010-12-22
7557	ORIG	2010-12-21
53245	ORIG	1900-01-01
53244	ORIG	1900-01-01
53243	ORIG	1900-01-01