Application 076381

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JUNEL 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL-21	0.03MG;1.5MG	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
A076381-001	JUNEL 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET / ORAL-21	AB		2003-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076381-001	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	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076381-001	JUNEL 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-05-30	`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	A076381-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076381-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076381-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076381-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076381-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076381-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076381-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076381-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076381-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076381-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076381-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076381-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076381-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076381-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076381-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076381-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076381-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076381-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076381-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076381-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076381-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076381-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076381-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076381-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076381-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076381-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076381-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076381-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076381-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076381-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076381-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076381-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076381-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076381-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076381-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076381-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076381-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076381-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076381-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076381-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Junel 21 Day	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	8b82ad14-580c-4145-b825-dce849f95363	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076381 application number: ANDA076381 ndc (product): 0555-9027
Loestrin Fe 28 Day	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Teva Women's Health LLC	f29ebcb5-7e65-4092-bfaa-f5ec026fc255	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076381 application number: ANDA076381 ndc (product): 51285-127

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
0555-9027	Junel	Norethindrone Acetate and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9027	Junel	Norethindrone Acetate and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9027	Junel	Norethindrone Acetate and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9027	Junel	Norethindrone Acetate and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9027	Junel	Norethindrone Acetate and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9027	Junel	Norethindrone Acetate and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
51285-127	Loestrin	Norethindrone Acetate and Ethinyl Estradiol	Teva Women's Health, Inc.	ANDA	Current
51285-127	Loestrin	Norethindrone Acetate and Ethinyl Estradiol	Teva Women's Health, Inc.	ANDA	Current
51285-127	Loestrin	Norethindrone Acetate and Ethinyl Estradiol	Teva Women's Health, Inc.	ANDA	Current
51285-127	Loestrin	Norethindrone Acetate and Ethinyl Estradiol	Teva Women's Health, Inc.	ANDA	Current
51285-127	Loestrin	Norethindrone Acetate and Ethinyl Estradiol	Teva Women's Health, Inc.	ANDA	Current