Application 076455

Type: ANDA
Sponsor: DURAMED PHARMS BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VELIVET	DESOGESTREL; ETHINYL ESTRADIOL	TABLET;ORAL-28	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	No	No
002	DESOGESTREL; ETHINYL	DESOGESTREL; ETHINYL ESTRADIOL	Tablet; Oral	0.125MG/0.025MG	No	No
003	DESOGESTREL; ETHINYL	DESOGESTREL; ETHINYL ESTRADIOL	Tablet; Oral	0.15MG/0.025MG	No	No

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

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
A076455-001	VELIVET	DESOGESTREL; ETHINYL ESTRADIOL	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB		2004-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076455-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076455-001	VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET / ORAL-28	AB	2004-02-24	`f41ea6bd6efb…`

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	A076455-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076455-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076455-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076455-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076455-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076455-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076455-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076455-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076455-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076455-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076455-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076455-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076455-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076455-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076455-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076455-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076455-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076455-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076455-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076455-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076455-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076455-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076455-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076455-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076455-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076455-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076455-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076455-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076455-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076455-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076455-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076455-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076455-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076455-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076455-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076455-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076455-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076455-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076455-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076455-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Velivet Triphasic Regimen	DESOGESTREL AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	a3ce5125-62ba-4983-93f0-91f254271605	2022-09-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076455 application number: ANDA076455 ndc (product): 0555-9051

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-9051	Velivet	Desogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9051	Velivet	Desogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9051	Velivet	Desogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9051	Velivet	Desogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9051	Velivet	Desogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
51862-238	Caziant	Desogestrel and Ethinyl Estradiol	Mayne Pharma Inc.	ANDA	Current
51862-238	Caziant	Desogestrel and Ethinyl Estradiol	Mayne Pharma Inc.	ANDA	Current
53002-1628	Caziant	Desogestrel and Ethinyl Estradiol	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1628	Caziant	Desogestrel and Ethinyl Estradiol	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1775	Velivet	Desogestrel and Ethinyl Estradiol	RPK Pharmaceuticals, Inc.	ANDA	Current
70518-0059	Caziant	Desogestrel and Ethinyl Estradiol	REMEDYREPACK INC.	ANDA	Current