Application 076081

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JUNEL FE 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL-28	0.02MG;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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076081-001	JUNEL FE 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET / ORAL-28	AB		2003-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076081-001	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	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`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	A076081-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076081-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076081-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076081-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076081-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076081-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076081-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076081-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076081-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076081-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076081-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076081-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076081-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076081-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076081-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076081-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076081-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076081-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076081-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076081-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076081-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076081-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076081-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076081-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076081-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076081-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076081-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076081-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076081-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076081-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076081-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076081-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076081-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076081-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076081-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076081-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076081-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076081-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076081-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076081-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Junel Fe 28 Day	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	PD-Rx Pharmaceuticals, Inc.	93a2f8c9-3550-42ec-8f76-3ac9badf4bb2	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076081 application number: ANDA076081
Junel Fe 1/20	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE	Preferred Pharmaceuticals Inc.	75bb0024-8f1a-4036-9acd-006ea430f3b7	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076081 application number: ANDA076081 ndc (product): 68788-6832
Junel Fe 28 Day	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Bryant Ranch Prepack	13d7768b-ee41-46b0-93f4-5e8170dd338d	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076081 application number: ANDA076081
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): 076081 application number: ANDA076081 ndc (product): 0555-9026
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): 076081 application number: ANDA076081 ndc (product): 51285-125
Junel Fe 28 Day	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	A-S Medication Solutions	421b8cf7-119f-495a-b10a-bd864e87ab5a	2023-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076081 application number: ANDA076081 ndc (product): 50090-3237

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-9026	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9026	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9026	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9026	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9026	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9026	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50090-3237	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	A-S Medication Solutions	ANDA	Current
51285-125	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-125	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-125	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-125	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-125	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-126	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
68788-6832	Junel Fe 1/20	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6832	Junel Fe 1/20	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6832	Junel Fe 1/20	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6832	Junel Fe 1/20	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6832	Junel Fe 1/20	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current