Application 020907

Type: NDA
Sponsor: AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACTIVELLA	ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL	1MG;0.5MG	Yes	Yes
002	ACTIVELLA	ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL	0.5MG;0.1MG	Yes	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
N020907-001	ACTIVELLA	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18
N020907-002	ACTIVELLA	ESTRADIOL; NORETHINDRONE ACETATE	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020907-001	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 3 · 86 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	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020907-002	ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020907-002	ACTIVELLA	0.5MG;0.1MG	TABLET / ORAL		RLD	2006-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020907-002	ACTIVELLA	0.5MG;0.1MG	TABLET / ORAL		RLD	2006-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020907-002	ACTIVELLA	0.5MG;0.1MG	TABLET / ORAL		RLD	2006-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020907-001	ACTIVELLA	1MG;0.5MG	TABLET / ORAL	AB	RLD, RS	1998-11-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020907-002	ACTIVELLA	0.5MG;0.1MG	TABLET / ORAL	AB	RLD	2006-12-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 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	N020907-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020907-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020907-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020907-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020907-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020907-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020907-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020907-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020907-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020907-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020907-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020907-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020907-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020907-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020907-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020907-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020907-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020907-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020907-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020907-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020907-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020907-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020907-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020907-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020907-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020907-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020907-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020907-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020907-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020907-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020907-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020907-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020907-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020907-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020907-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020907-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020907-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020907-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020907-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020907-001	AB	1	`1c564ffb4f44…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOPREEZA	ESTRADIOL/NORETHINDRONE ACETATE	Amneal Pharmaceuticals NY LLC	966ac064-9eb7-4d15-b271-a7880ed1e79a	2025-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020907 application number: NDA020907 ndc (product): 69238-1610 ndc (product): 69238-1609
Activella	ESTRADIOL/NORETHINDRONE ACETATE	Amneal Pharmaceuticals LLC	d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0	2023-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020907 application number: NDA020907 ndc (product): 60846-232 ndc (product): 60846-231
Lopreeza	ESTRADIOL/NORETHINDRONE ACETATE	Amneal Pharmaceuticals NY LLC	bf0e39cb-95e7-4831-92d2-0b3f071aeaae	2017-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020907 application number: NDA020907 ndc (product): 69238-1252 ndc (product): 69238-1251

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 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60846-201	Activella	estradiol and norethindrone acetate	Gemini Laboratories, LLC	NDA	Current
60846-202	Activella	estradiol and norethindrone acetate	Gemini Laboratories, LLC	NDA	Current
60846-231	Activella	Estradiol/norethindrone acetate	Amneal Pharmaceuticals LLC	NDA	Current
60846-231	Activella	Estradiol/norethindrone acetate	Amneal Pharmaceuticals LLC	NDA	Current
60846-231	Activella	Estradiol/norethindrone acetate	Amneal Pharmaceuticals LLC	NDA	Current
60846-231	Activella	Estradiol/norethindrone acetate	Gemini Laboratories, LLC	NDA	Current
60846-232	Activella	Estradiol/norethindrone acetate	Amneal Pharmaceuticals LLC	NDA	Current
60846-232	Activella	Estradiol/norethindrone acetate	Gemini Laboratories, LLC	NDA	Current
60846-232	Activella	Estradiol/norethindrone acetate	Amneal Pharmaceuticals LLC	NDA	Current
60846-232	Activella	Estradiol/norethindrone acetate	Amneal Pharmaceuticals LLC	NDA	Current
60846-232	Activella	Estradiol/norethindrone acetate	Amneal Pharmaceuticals LLC	NDA	Current
60846-232	Activella	Estradiol/norethindrone acetate	Gemini Laboratories, LLC	NDA	Current
69238-1251	Lopreeza	estradiol/norethindrone acetate	Amneal Pharmaceuticals NY LLC	NDA AUTHORIZED GENERIC	Current
69238-1251	Lopreeza	estradiol/norethindrone acetate	Amneal Pharmaceuticals NY LLC	NDA AUTHORIZED GENERIC	Current
69238-1251	Lopreeza	estradiol/norethindrone acetate	Amneal Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
69238-1251	Lopreeza	estradiol/norethindrone acetate	Amneal Pharmaceuticals NY LLC	NDA AUTHORIZED GENERIC	Current
69238-1252	Lopreeza	estradiol/norethindrone acetate	Amneal Pharmaceuticals NY LLC	NDA AUTHORIZED GENERIC	Current
69238-1252	Lopreeza	estradiol/norethindrone acetate	Amneal Pharmaceuticals NY LLC	NDA AUTHORIZED GENERIC	Current
69238-1252	Lopreeza	estradiol/norethindrone acetate	Amneal Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
69238-1252	Lopreeza	estradiol/norethindrone acetate	Amneal Pharmaceuticals NY LLC	NDA AUTHORIZED GENERIC	Current
69238-1609	LOPREEZA	estradiol/norethindrone acetate	Amneal Pharmaceuticals NY LLC	NDA	Current
69238-1609	LOPREEZA	estradiol/norethindrone acetate	Amneal Pharmaceuticals LLC	NDA	Current
69238-1610	LOPREEZA	estradiol/norethindrone acetate	Amneal Pharmaceuticals NY LLC	NDA	Current
69238-1610	LOPREEZA	estradiol/norethindrone acetate	Amneal Pharmaceuticals LLC	NDA	Current
69238-1610	LOPREEZA	estradiol/norethindrone acetate	Amneal Pharmaceuticals NY LLC	NDA	Current
69238-1610	LOPREEZA	estradiol/norethindrone acetate	Amneal Pharmaceuticals NY LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77527	SUPPL	2024-02-16
77520	SUPPL	2024-02-16
68347	SUPPL	2021-08-11
68336	SUPPL	2021-08-11
68334	SUPPL	2021-08-11
62510	SUPPL	2020-04-09
50631	SUPPL	2017-12-07
50291	SUPPL	2017-11-03
13724	SUPPL	2013-10-17
26174	SUPPL	2013-10-10
35625	SUPPL	2007-01-08
35624	SUPPL	2007-01-08
26173	SUPPL	2007-01-08
26172	SUPPL	2007-01-08
41805	SUPPL	2005-12-08
41804	SUPPL	2005-12-08
41803	SUPPL	2005-12-08
41802	SUPPL	2005-12-08
21271	SUPPL	2005-12-08
21270	SUPPL	2005-12-08
26171	SUPPL	2005-07-08
35623	SUPPL	2005-07-07
41801	ORIG	1998-11-18
35622	ORIG	1998-11-18
26170	ORIG	1998-11-18