Application 075803

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LESSINA-21	ETHINYL ESTRADIOL; LEVONORGESTREL	TABLET;ORAL-21	0.02MG;0.1MG	No	No
002	LESSINA-28	ETHINYL ESTRADIOL; LEVONORGESTREL	TABLET;ORAL-28	0.02MG;0.1MG	No	No

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
A075803-001	LESSINA-21	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET / ORAL-21			2002-03-20
A075803-002	LESSINA-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET / ORAL-28	AB2		2002-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075803-002	AB2

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075803-001	LESSINA-21	0.02MG;0.1MG	TABLET / ORAL-21		2002-03-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075803-002	LESSINA-28	0.02MG;0.1MG	TABLET / ORAL-28	AB2	2002-03-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A075803-002	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075803-002	AB2	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075803-002	AB2	1	`a50c72e98297…`

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
Lessina	LEVONORGESTREL AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	a5fd1b3a-019c-4871-95b3-a45bbbd46f82	2021-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075803 application number: ANDA075803 ndc (product): 0555-9014

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-9014	Lessina	Levonorgestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9014	Lessina	Levonorgestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9014	Lessina	Levonorgestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9014	Lessina	Levonorgestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39492	ORIG	2003-12-24
22503	ORIG	2003-12-24
8795	ORIG	2003-04-10