Application 076064

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JUNEL FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL-28	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
A076064-001	JUNEL FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	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
A076064-001	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB		2003-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	2003-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076064-001	JUNEL FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	RS	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	A076064-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076064-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076064-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076064-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076064-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076064-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076064-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076064-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076064-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076064-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076064-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076064-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076064-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076064-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076064-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076064-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076064-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076064-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076064-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076064-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076064-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076064-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076064-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076064-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076064-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076064-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076064-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076064-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076064-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076064-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076064-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076064-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076064-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076064-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076064-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076064-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076064-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076064-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076064-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076064-001	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 · 4 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	A-S Medication Solutions	0428e1fd-3e1b-44fe-83fe-cf6be0915552	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076064 application number: ANDA076064
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): 076064 application number: ANDA076064 ndc (product): 0555-9028
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): 076064 application number: ANDA076064 ndc (product): 51285-128
Junel Fe 1.5/30	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE	Proficient Rx LP	253c6b2e-2c93-4ee7-94a6-fd063c569c1f	2022-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076064 application number: ANDA076064 ndc (product): 63187-890

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-9028	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9028	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9028	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9028	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9028	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-9028	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42254-242	Junel Fe 1.5/30	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Rebel Distributors Corp	ANDA	Current
51285-128	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-128	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-128	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-128	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-128	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
51285-129	Loestrin	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Teva Women's Health, Inc.	ANDA	Current
63187-890	Junel Fe 1.5/30	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Proficient Rx LP	ANDA	Current
63187-890	Junel Fe 1.5/30	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Proficient Rx LP	ANDA	Current
63187-890	Junel Fe 1.5/30	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Proficient Rx LP	ANDA	Current
63187-890	Junel Fe 1.5/30	norethindrone acetate and ethinyl estradiol, and ferrous fumarate	Proficient Rx LP	ANDA	Current
68788-8113	Junel	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current