Application 020538

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTRADIOL	ESTRADIOL	Film, Extended Release; Transdermal	0.0375MG/24HR	No	No
002	ESTRADIOL	ESTRADIOL	Film, Extended Release; Transdermal	0.075MG/24HR	No	No
003	ESTRADIOL	ESTRADIOL	Film, Extended Release; Transdermal	0.05MG/24HR	No	No
004	ESTRADIOL	ESTRADIOL	Film, Extended Release; Transdermal	0.1MG/24HR	No	No
005	VIVELLE-DOT	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.0375MG/24HR	Yes	No
006	VIVELLE-DOT	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/24HR	Yes	No
007	VIVELLE-DOT	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.075MG/24HR	Yes	No
008	VIVELLE-DOT	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	Yes	Yes
009	VIVELLE-DOT	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.025MG/24HR	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	RLD / RS	Approval date
N020538-005	VIVELLE-DOT	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08
N020538-006	VIVELLE-DOT	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08
N020538-007	VIVELLE-DOT	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08
N020538-008	VIVELLE-DOT	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08
N020538-009	VIVELLE-DOT	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N020538-005	AB1
N020538-006	AB1
N020538-007	AB1
N020538-008	AB1
N020538-009	AB1

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 · 220 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
2026-10-15 13:18:30	2026-09	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-005	VIVELLE-DOT	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-006	VIVELLE-DOT	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-007	VIVELLE-DOT	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	1999-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-008	VIVELLE-DOT	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD, RS	1999-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-009	VIVELLE-DOT	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	RLD	2002-05-03	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020538-005	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-006	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-007	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-008	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020538-009	AB1	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020538-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020538-009	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020538-005	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-006	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-007	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-008	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020538-009	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020538-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020538-009	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-005	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-006	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-007	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-008	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020538-009	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020538-005	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-006	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-007	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-008	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020538-009	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-005	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-006	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-007	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-008	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020538-009	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-005	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-006	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-007	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-008	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020538-009	AB1	1	`b8a1b40f171c…`

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 6 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	1bbdb10b-9a32-3899-e063-6294a90ab26d	2024-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	NuCare Pharmaceuticals,Inc.	7093dbe4-b096-2ddb-e053-2991aa0a1bb8	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
ESTRACE	ESTRADIOL	Allergan, Inc.	dfc41fcd-c5ba-4b25-b647-cf04d3988b3e	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Amneal Pharmaceuticals NY LLC	d4259bb8-91f8-4587-8ceb-35d44145aec0	2024-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
LYLLANA	ESTRADIOL	Amneal Pharmaceuticals LLC	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	2024-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Amneal Pharmaceuticals NY LLC	0500ee9b-bf4a-4432-9afe-20a7d60a6fe5	2024-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
DOTTI	ESTRADIOL	Amneal Pharmaceuticals LLC	53016d30-6b5f-49da-ac16-85ef415a5805	2024-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	0e927450-3f02-4d2f-9235-a255357e8d93	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	6a4e82a4-d980-4c04-9e33-9444a292728a	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	eab9a629-b3d4-4faf-bce4-656fe3b46d38	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Estradiol	ESTRADIOL	ANI Pharmaceuticals, Inc.	3fe899db-a8cd-4a31-88fb-1129be96b4d9	2024-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Noven Therapeutics, LLC	bf185599-2138-4083-9c52-2b95dce09ae0	2024-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	80d6644a-d6f2-48e7-a685-92c4255b19fe	2024-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	414b846a-d6d9-4e8a-9632-12e296fc13c3	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
YUVAFEM	ESTRADIOL	Amneal Pharmaceuticals LLC	30c7f6ba-7a9e-4853-b3e4-e00a46560224	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Amneal Pharmaceuticals of New York LLC	094830ee-1b1c-4cf7-8a39-427dfd56f9c9	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	8cb31c7c-fba8-4201-833d-844ea1a8a4de	2024-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	684850eb-d889-4370-a0a7-4a5c3113266a	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: estradiol generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	db4696da-7820-4b2b-97b4-fb05b1208020	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	839fe7ae-6835-4d6a-b6b1-ca7f062caa4f	2024-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL

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 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0343	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0343	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0343	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0343	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0343	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0344	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0344	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0344	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0344	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0344	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0345	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0345	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0345	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0345	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0345	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0346	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0346	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0346	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0346	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0346	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0365	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0365	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0365	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0365	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0365	Vivelle-Dot	estradiol	Novartis Pharmaceuticals Corporation	NDA	Current
0781-7129	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7129	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7129	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7129	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7129	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7138	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7138	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7138	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7138	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7138	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7144	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7144	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7144	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7144	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7144	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7156	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7156	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7156	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7156	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7156	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7167	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7167	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7167	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7167	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7167	Estradiol	estradiol	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
68071-3326	Estradiol	estradiol	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-3326	Estradiol	estradiol	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77569	SUPPL	2024-02-20
77546	SUPPL	2024-02-16
69008	SUPPL	2021-10-15
68886	SUPPL	2021-10-05
68885	SUPPL	2021-10-05
68874	SUPPL	2021-10-05
68873	SUPPL	2021-10-05
68541	SUPPL	2021-09-03
50287	SUPPL	2017-11-03
12696	SUPPL	2014-08-01
2687	SUPPL	2014-08-01
34795	SUPPL	2013-05-21
34794	SUPPL	2013-05-21
25134	SUPPL	2013-05-21
25133	SUPPL	2013-05-21
12695	SUPPL	2013-05-21
2686	SUPPL	2013-05-21
41418	SUPPL	2006-05-16
25132	SUPPL	2004-08-10
12694	SUPPL	2004-08-10
12693	SUPPL	2004-02-03
25131	SUPPL	2004-02-02
34793	SUPPL	2002-05-03
34792	SUPPL	2002-05-03
34791	SUPPL	2002-05-03
2685	SUPPL	2002-05-03
2684	SUPPL	2002-05-03
2683	SUPPL	2002-05-03
20708	SUPPL	1999-01-08
12692	SUPPL	1999-01-08
2682	SUPPL	1999-01-08