Application 020655

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALORA	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/24HR	No	No
002	ALORA	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.075MG/24HR	No	No
003	ALORA	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	No	No
004	ALORA	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N020655-001	ALORA	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20
N020655-002	ALORA	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20
N020655-003	ALORA	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20
N020655-004	ALORA	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2002-04-05

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 5 · 172 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	N020655-001	ALORA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020655-002	ALORA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020655-003	ALORA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020655-004	ALORA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2002-04-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020655-001	ALORA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020655-002	ALORA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020655-003	ALORA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020655-004	ALORA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2002-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020655-001	ALORA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020655-002	ALORA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020655-003	ALORA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020655-004	ALORA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2002-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020655-001	ALORA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020655-002	ALORA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020655-003	ALORA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020655-004	ALORA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2002-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020655-001	ALORA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020655-002	ALORA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020655-003	ALORA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020655-004	ALORA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2002-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020655-001	ALORA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020655-002	ALORA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020655-003	ALORA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020655-004	ALORA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2002-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020655-001	ALORA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020655-002	ALORA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020655-003	ALORA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020655-004	ALORA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2002-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020655-001	ALORA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020655-002	ALORA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020655-003	ALORA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020655-004	ALORA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2002-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020655-001	ALORA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020655-002	ALORA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020655-003	ALORA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020655-004	ALORA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2002-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020655-001	ALORA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020655-002	ALORA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020655-003	ALORA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1996-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020655-004	ALORA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2002-04-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020655-001	BX	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020655-002	BX	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020655-003	BX	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020655-004	BX	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020655-001	BX	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020655-002	BX	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020655-003	BX	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020655-004	BX	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020655-001	BX	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020655-002	BX	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020655-003	BX	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020655-004	BX	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020655-001	BX	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020655-002	BX	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020655-003	BX	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020655-004	BX	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020655-001	BX	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020655-002	BX	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020655-003	BX	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020655-004	BX	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020655-001	BX	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020655-002	BX	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020655-003	BX	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020655-004	BX	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020655-001	BX	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020655-002	BX	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020655-003	BX	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020655-004	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020655-001	BX	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020655-002	BX	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020655-003	BX	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020655-004	BX	1	`ea99ee380514…`

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 7 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	8cb31c7c-fba8-4201-833d-844ea1a8a4de	2024-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	684850eb-d889-4370-a0a7-4a5c3113266a	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	db4696da-7820-4b2b-97b4-fb05b1208020	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	839fe7ae-6835-4d6a-b6b1-ca7f062caa4f	2024-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Sandoz Inc	c4da6de7-9ab1-4fcf-88f3-fe785019e6e7	2024-02-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	c4936878-1643-4e7f-9b0d-e4957935aef2	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ELESTRIN	ESTRADIOL	Viatris Specialty LLC	eff2dea1-f117-11e3-ac10-0800200c9a66	2023-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	31646359-292c-4bca-88a4-7a89b11c3f44	2023-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Vivelle-Dot	ESTRADIOL	Sandoz Inc	5ccb77f9-d47b-4381-ad5c-5b92524e1c4a	2023-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estrogen 4X	ESTRADIOL	Nutritional Specialties, Inc.	772c2a8a-10e2-49af-8db6-4d5ca64b1719	2023-07-25	Warnings	Name fallback generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Lifesciences Limited	2f2030c2-f72e-4142-9cff-540bc8fbf8a1	2023-04-21		Name fallback generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Lifesciences Limited	8b672c79-0896-4d6e-b225-299e89068ad7	2023-04-21		Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Zydus Lifesciences Limited	b79fd5ea-962f-491c-b670-40efe42ccf79	2022-12-07		Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Asclemed USA, Inc.	229b4ec5-d3c8-4406-9fc5-8f633c6447b8	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	PharmPak, Inc.	8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	2022-10-09	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-5885	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5885	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5885	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5885	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5885	Alora	Estradiol Transdermal System	Allergan, Inc.	NDA	Current
0023-5886	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5886	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5886	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5886	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5886	Alora	Estradiol Transdermal System	Allergan, Inc.	NDA	Current
0023-5887	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5887	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5887	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5887	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5887	Alora	Estradiol Transdermal System	Allergan, Inc.	NDA	Current
0023-5888	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5888	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5888	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5888	Alora	Estradiol	Allergan, Inc.	NDA	Current
0023-5888	Alora	Estradiol Transdermal System	Allergan, Inc.	NDA	Current
52544-471	Alora	Estradiol	Actavis Pharma, Inc.	NDA	Current
52544-471	Alora	Estradiol	Actavis Pharma, Inc.	NDA	Current
52544-471	Alora	Estradiol	Actavis Pharma, Inc.	NDA	Current
52544-471	Alora	Estradiol Transdermal System	Actavis Pharma, Inc.	NDA	Current
52544-472	Alora	Estradiol	Actavis Pharma, Inc.	NDA	Current
52544-472	Alora	Estradiol	Actavis Pharma, Inc.	NDA	Current
52544-472	Alora	Estradiol	Actavis Pharma, Inc.	NDA	Current
52544-472	Alora	Estradiol Transdermal System	Actavis Pharma, Inc.	NDA	Current
52544-473	Alora	Estradiol	Actavis Pharma, Inc.	NDA	Current
52544-473	Alora	Estradiol	Actavis Pharma, Inc.	NDA	Current
52544-473	Alora	Estradiol	Actavis Pharma, Inc.	NDA	Current
52544-473	Alora	Estradiol Transdermal System	Actavis Pharma, Inc.	NDA	Current
52544-884	Alora	Estradiol	Actavis Pharma, Inc.	NDA	Current
52544-884	Alora	Estradiol	Actavis Pharma, Inc.	NDA	Current
52544-884	Alora	Estradiol	Actavis Pharma, Inc.	NDA	Current
52544-884	Alora	Estradiol Transdermal System	Actavis Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82164	SUPPL	2025-05-08
82260	SUPPL	2025-05-05
77530	SUPPL	2024-02-16
77517	SUPPL	2024-02-16
62369	SUPPL	2020-03-31
62367	SUPPL	2020-03-31
50261	SUPPL	2017-11-02
35078	SUPPL	2005-05-20
25447	SUPPL	2005-05-20
41523	SUPPL	2004-05-27
12923	SUPPL	2003-12-01
25446	SUPPL	2003-11-26
12924	SUPPL	2002-04-05
2998	SUPPL	2002-04-05