Application 201088

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIENVA	ETHINYL ESTRADIOL; LEVONORGESTREL	TABLET;ORAL-28	0.02MG;0.1MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A201088-001	VIENVA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET / ORAL-28	AB1		2015-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201088-001	AB1

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 · 42 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
2026-08-18 06:07:40	2026-07	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201088-001	VIENVA	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2015-05-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201088-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201088-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201088-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201088-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201088-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201088-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201088-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201088-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201088-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201088-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201088-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201088-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201088-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201088-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201088-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201088-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201088-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201088-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201088-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201088-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201088-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201088-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201088-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201088-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201088-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201088-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201088-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201088-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201088-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201088-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201088-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201088-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201088-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201088-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201088-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201088-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201088-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201088-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201088-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201088-001	AB1	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VIENVA TM	LEVONORGESTREL AND ETHINYL ESTRADIOL	A-S Medication Solutions	f6825c1a-ba78-47aa-9622-12e59517ab1a	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201088 application number: ANDA201088 ndc (product): 50090-5580
Vienva TM	LEVONORGESTREL AND ETHINYL ESTRADIOL	Bryant Ranch Prepack	8b1b92f7-b736-436d-b06d-1fedeb970408	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201088 application number: ANDA201088 ndc (product): 63629-2344
Vienva	LEVONORGESTREL AND ETHINYL ESTRADIOL	Xiromed, LLC.	58ea31df-f9cf-7d00-c2db-0529fb9a3e53	2024-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201088 application number: ANDA201088 ndc (product): 70700-118

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
0254-2032	Orsythia	Levonorgestrel and Ethinyl Estradiol	Par Pharmaceutical, Inc.	ANDA	Current
0254-2032	Orsythia	Levonorgestrel and Ethinyl Estradiol	Par Pharmaceutical, Inc.	ANDA	Current
0781-5575	Vienva TM	Levonorgestrel and Ethinyl Estradiol	Sandoz Inc	ANDA	Current
50090-4303	Orsythia	Levonorgestrel and Ethinyl Estradiol	A-S Medication Solutions	ANDA	Current
50090-5580	Vienva TM	Levonorgestrel and Ethinyl Estradiol	A-S Medication Solutions	ANDA	Current
53002-3647	Orsythia	Levonorgestrel and Ethinyl Estradiol	RPK Pharmaceuticals, Inc.	ANDA	Current
63629-2344	Vienva TM	Levonorgestrel and Ethinyl Estradiol	Bryant Ranch Prepack	ANDA	Current
63629-2344	Vienva TM	Levonorgestrel and Ethinyl Estradiol	Bryant Ranch Prepack	ANDA	Current
63629-2344	Vienva TM	Levonorgestrel and Ethinyl Estradiol	Bryant Ranch Prepack	ANDA	Current
70518-1325	Vienva TM	Levonorgestrel and Ethinyl Estradiol	REMEDYREPACK INC.	ANDA	Current
70518-1325	Vienva TM	Levonorgestrel and Ethinyl Estradiol	REMEDYREPACK INC.	ANDA	Current
70700-118	Vienva TM	Levonorgestrel and Ethinyl Estradiol	Xiromed, LLC.	ANDA	Current
70700-118	Vienva TM	Levonorgestrel and Ethinyl Estradiol	Xiromed, LLC.	ANDA	Current
70700-118	Vienva TM	Levonorgestrel and Ethinyl Estradiol	Xiromed, LLC.	ANDA	Current
70700-118	Vienva TM	Levonorgestrel and Ethinyl Estradiol	Xiromed, LLC.	ANDA	Current
70700-118	Vienva TM	Levonorgestrel and Ethinyl Estradiol	Xiromed, LLC.	ANDA	Current