Application 040312

Type: ANDA
Sponsor: NOVO NORDISK INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INNOFEM	ESTRADIOL	TABLET;ORAL	0.5MG	No	No
002	INNOFEM	ESTRADIOL	TABLET;ORAL	1MG	No	No
003	INNOFEM	ESTRADIOL	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040312-001	INNOFEM	ESTRADIOL	0.5MG	TABLET / ORAL	1999-11-19
A040312-002	INNOFEM	ESTRADIOL	1MG	TABLET / ORAL	1999-11-19
A040312-003	INNOFEM	ESTRADIOL	2MG	TABLET / ORAL	1999-11-19

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040312-002	INNOFEM	1MG	TABLET / ORAL	1999-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040312-003	INNOFEM	2MG	TABLET / ORAL	1999-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040312-001	INNOFEM	0.5MG	TABLET / ORAL	1999-11-19	`301d65b070ca…`

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 2 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESTRADIOL	ESTRADIOL	Encube Ethicals, Inc.	54f108d6-ddd2-4276-8508-2c8e16a65fb2	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol Gel	ESTRADIOL	Encube Ethicals, Inc.	d4a3606f-83b2-45df-bc77-faebfa796f9a	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estring	ESTRADIOL	Pfizer Laboratories Div Pfizer Inc	110b9865-5a07-4d45-b560-e89947f12600	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol Vaginal	ESTRADIOL	A-S Medication Solutions	0137d491-6917-4060-9b32-e0cd7b0badbb	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Preferred Pharmaceuticals, Inc.	6d129a94-8ecd-40a3-9a95-c5e1ece41ab1	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol Vaginal	ESTRADIOL	Bryant Ranch Prepack	67f581cb-6d77-49fc-b2f3-976e3b57dcbf	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Climara	ESTRADIOL	Bayer HealthCare Pharmaceuticals Inc.	1e9702c4-f2d7-4ea8-b6e8-7dca31671864	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Menostar	ESTRADIOL	Bayer HealthCare Pharmaceuticals Inc.	a78708cd-04d4-4221-a4e4-53680bbe2912	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol Transdermal System	ESTRADIOL	Sandoz Inc	c714974b-766f-42f2-a846-b0c1f5a60560	2026-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Padagis Israel Pharmaceuticals Ltd	3ac905b3-904c-4285-97ed-e787d006c7dd	2026-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
DIVIGEL	ESTRADIOL	Vertical Pharmaceuticals, LLC	59e610dc-883e-4f07-9ec6-a5841b0bf9fb	2026-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	98770987-b313-4f2a-9aac-db0ab2068cc6	2026-02-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	REMEDYREPACK INC.	170ec388-d399-4543-8743-208394b38904	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Solaris Pharma Corporation	67e8665c-5331-423c-99fd-546ab6cccb07	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Yuvafem	ESTRADIOL	AvKARE	d20abc9a-8f47-e274-c9b1-b71c9489761f	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol Vaginal	ESTRADIOL	AvKARE	bb7b442d-b8c3-b7f0-e053-2a95a90a2c94	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol 1557	ESTRADIOL	Professional Complementary Health Formulas	f0da282a-6c7e-4a18-870f-d0d8efc2c7e9	2026-01-08	Warnings	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Direct_Rx	47e446f8-ac16-ea6b-e063-6394a90a1726	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Northwind Health Company, LLC	106b92da-334c-542f-e063-6394a90aa65b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Northwind Health Company, LLC	0a1e744c-7926-0e0c-e063-6294a90a80d0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22124	ORIG	1999-11-19
7620	ORIG	1999-11-19