Application 075256

Type: ANDA
Sponsor: DURAMED PHARMS BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	TABLET;ORAL-21	0.15MG;0.03MG	No	No
002	DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	TABLET;ORAL-28	0.15MG;0.03MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12
A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075256-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075256-001	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-21			1999-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075256-002	DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET / ORAL-28	AB	RS	1999-08-12	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075256-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075256-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075256-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075256-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075256-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075256-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075256-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075256-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075256-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075256-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075256-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075256-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075256-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075256-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075256-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075256-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075256-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075256-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075256-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075256-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075256-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075256-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075256-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075256-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075256-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075256-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075256-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075256-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075256-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075256-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075256-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075256-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075256-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075256-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075256-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075256-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075256-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075256-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075256-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075256-002	AB	1	`f41ea6bd6efb…`

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
Apri 28 Day	DESOGESTREL AND ETHINYL ESTRADIOL	A-S Medication Solutions	3448d121-d00a-4752-8782-416b7a376f3f	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075256 application number: ANDA075256 ndc (product): 50090-2481
Reclipsen 28 Day	DESOGESTREL AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	a1e00bc6-7487-4057-9dcc-d0e2327d1d12	2022-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075256 application number: ANDA075256 ndc (product): 0093-3304
Apri 28 Day	DESOGESTREL AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	a9e08f9b-9862-4c2c-8302-53dc82d85126	2021-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075256 application number: ANDA075256 ndc (product): 0555-9043

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3304	Reclipsen	Desogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3304	Reclipsen	Desogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9043	Apri	Desogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9043	Apri	Desogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9043	Apri	Desogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9043	Apri	Desogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50090-2481	Apri	Desogestrel and Ethinyl Estradiol	A-S Medication Solutions	ANDA	Current
50090-2481	Apri	Desogestrel and Ethinyl Estradiol	A-S Medication Solutions	ANDA	Current
53002-1631	Reclipsen	Desogestrel and Ethinyl Estradiol	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1631	Reclipsen	Desogestrel and Ethinyl Estradiol	RPK Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39474	SUPPL	2004-06-02
39473	SUPPL	2004-06-02
39472	SUPPL	2004-06-02
39471	SUPPL	2004-06-02
39470	SUPPL	2004-06-02
30821	SUPPL	2004-06-02
30820	SUPPL	2004-06-02
30819	SUPPL	2004-06-02
30818	SUPPL	2004-06-02
18397	SUPPL	2004-06-02
18396	SUPPL	2004-06-02
18395	ORIG	2004-06-02
8587	SUPPL	2004-06-02
8586	SUPPL	2004-06-02
8585	SUPPL	2004-06-02
42967	SUPPL	2003-07-29
42966	SUPPL	2003-07-29
42965	SUPPL	2003-07-29
22448	SUPPL	2003-07-29
22447	SUPPL	2003-07-29
22446	SUPPL	2003-07-29
22445	SUPPL	2003-07-29
22444	ORIG	2003-07-29
8584	ORIG	1999-08-12