Application 090114

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYEDA	DROSPIRENONE; ETHINYL ESTRADIOL	TABLET;ORAL-28	3MG;0.03MG	No	No

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
A090114-001	SYEDA	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB		2011-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090114-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090114-001	SYEDA	3MG;0.03MG	TABLET / ORAL-28	AB	2011-03-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090114-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090114-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090114-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090114-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090114-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090114-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090114-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090114-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090114-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090114-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090114-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090114-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090114-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090114-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090114-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090114-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090114-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090114-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090114-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090114-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090114-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090114-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090114-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090114-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090114-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090114-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090114-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090114-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090114-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090114-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090114-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090114-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090114-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090114-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090114-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090114-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090114-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090114-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090114-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090114-001	AB	1	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Syeda	DROSPIRENONE AND ETHINYL ESTRADIOL	Bryant Ranch Prepack	4424505f-acae-43ba-8a75-eadd0e283b23	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090114 application number: ANDA090114 ndc (product): 63629-2335
Syeda	DROSPIRENONE AND ETHINYL ESTRADIOL	Xiromed, LLC.	e1586633-1973-c396-6f4a-4c55cce4b59e	2023-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090114 application number: ANDA090114 ndc (product): 70700-115

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5658	Syeda	Drospirenone and Ethinyl Estradiol	Sandoz Inc	ANDA	Current
63629-2335	Syeda	Drospirenone and Ethinyl Estradiol	Bryant Ranch Prepack	ANDA	Current
63629-2335	Syeda	Drospirenone and Ethinyl Estradiol	Bryant Ranch Prepack	ANDA	Current
63629-2335	Syeda	Drospirenone and Ethinyl Estradiol	Bryant Ranch Prepack	ANDA	Current
70700-115	Syeda	Drospirenone and Ethinyl Estradiol	Xiromed, LLC.	ANDA	Current
70700-115	Syeda	Drospirenone and Ethinyl Estradiol	Xiromed, LLC.	ANDA	Current
70700-115	Syeda	Drospirenone and Ethinyl Estradiol	Xiromed, LLC.	ANDA	Current
70700-115	Syeda	Drospirenone and Ethinyl Estradiol	Xiromed, LLC.	ANDA	Current
70700-115	Syeda	Drospirenone and Ethinyl Estradiol	Xiromed, LLC.	ANDA	Current