Application 020323

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIVELLE	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.0375MG/24HR	No	No
002	VIVELLE	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/24HR	No	No
003	VIVELLE	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.075MG/24HR	No	No
004	VIVELLE	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	No	No
005	VIVELLE	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.025MG/24HR	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N020323-001	VIVELLE	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28
N020323-002	VIVELLE	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28
N020323-003	VIVELLE	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28
N020323-004	VIVELLE	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28
N020323-005	VIVELLE	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	2000-08-16

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 6 · 215 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	N020323-001	VIVELLE	0.0375MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020323-002	VIVELLE	0.05MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020323-003	VIVELLE	0.075MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020323-004	VIVELLE	0.1MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020323-005	VIVELLE	0.025MG/24HR	SYSTEM / TRANSDERMAL	2000-08-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020323-001	VIVELLE	0.0375MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020323-002	VIVELLE	0.05MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020323-003	VIVELLE	0.075MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020323-004	VIVELLE	0.1MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020323-005	VIVELLE	0.025MG/24HR	SYSTEM / TRANSDERMAL	2000-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020323-001	VIVELLE	0.0375MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020323-002	VIVELLE	0.05MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020323-003	VIVELLE	0.075MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020323-004	VIVELLE	0.1MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020323-005	VIVELLE	0.025MG/24HR	SYSTEM / TRANSDERMAL	2000-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020323-001	VIVELLE	0.0375MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020323-002	VIVELLE	0.05MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020323-003	VIVELLE	0.075MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020323-004	VIVELLE	0.1MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020323-005	VIVELLE	0.025MG/24HR	SYSTEM / TRANSDERMAL	2000-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020323-001	VIVELLE	0.0375MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020323-002	VIVELLE	0.05MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020323-003	VIVELLE	0.075MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020323-004	VIVELLE	0.1MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020323-005	VIVELLE	0.025MG/24HR	SYSTEM / TRANSDERMAL	2000-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020323-001	VIVELLE	0.0375MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020323-002	VIVELLE	0.05MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020323-003	VIVELLE	0.075MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020323-004	VIVELLE	0.1MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020323-005	VIVELLE	0.025MG/24HR	SYSTEM / TRANSDERMAL	2000-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020323-001	VIVELLE	0.0375MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020323-002	VIVELLE	0.05MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020323-003	VIVELLE	0.075MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020323-004	VIVELLE	0.1MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020323-005	VIVELLE	0.025MG/24HR	SYSTEM / TRANSDERMAL	2000-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020323-001	VIVELLE	0.0375MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020323-002	VIVELLE	0.05MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020323-003	VIVELLE	0.075MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020323-004	VIVELLE	0.1MG/24HR	SYSTEM / TRANSDERMAL	1994-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020323-005	VIVELLE	0.025MG/24HR	SYSTEM / TRANSDERMAL	2000-08-16	`03ed91905a0d…`

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 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	A-S Medication Solutions	c8a2d29c-299c-4559-b859-87b303a4af81	2026-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Trigen Laboratories, LLC	e84ad638-6768-41aa-b2b8-e2514ef63881	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL VAGINAL	ESTRADIOL	Redpharm Drug	58beabb8-6902-b26a-e063-6294a90a67f8	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Minivelle	ESTRADIOL	Noven Therapeutics, LLC	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Redpharm Drug	5718f042-e8c0-b721-e063-6294a90a5bef	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	A-S Medication Solutions	5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	ANI Pharmaceuticals, Inc.	ff28c624-906d-459c-8b8c-27cb1a664e12	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol Vaginal	ESTRADIOL	Redpharm Drug	546c168d-2a85-69b6-e063-6294a90a22ac	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	e6bf2abc-71ae-4e79-a37b-164c98ba746a	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	34bcec8e-c7a6-4a1c-9884-4d4efe024bb9	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	REMEDYREPACK INC.	41f7a56c-4ce3-4cc6-803e-1ff662efef90	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	REMEDYREPACK INC.	59a4b68d-a507-4809-a0c8-fd9799986d12	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	ba935918-39b3-4b56-bd83-78a29958e6d8	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	1c38f0d0-a360-4b66-bc0e-7d54e92465a1	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	REMEDYREPACK INC.	477cb52e-8ce2-491f-94a0-869ff60bf7ab	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	eacafc4a-2fa8-403d-8df7-2bc92d73a54f	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	ee5460ab-27e7-487a-a89c-bf8735399be6	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	REMEDYREPACK INC.	774ee81b-8e29-46af-ab12-7157f63b443b	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
EstroGel	ESTRADIOL	ASCEND Therapeutics US, LLC	762ac371-bb8b-47e7-b48f-e80d452c9dd4	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	A-S Medication Solutions	afd70875-0a93-40a7-842e-f4359818c2d9	2026-05-27	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
77567	SUPPL	2024-02-20
77543	SUPPL	2024-02-16
50302	SUPPL	2017-11-06
50286	SUPPL	2017-11-03
34502	SUPPL	2004-08-10
24774	SUPPL	2004-08-10
20597	SUPPL	2004-04-13
20596	SUPPL	2004-03-28
34501	SUPPL	2004-02-03
34500	SUPPL	2004-02-03
34498	SUPPL	2004-02-03
24773	SUPPL	2004-02-02
24772	SUPPL	2004-02-02
24769	SUPPL	2004-02-02
24771	SUPPL	2000-08-16
12441	SUPPL	2000-08-16
24770	SUPPL	2000-02-29
34499	SUPPL	2000-02-28