Application 211293

Type: ANDA
Sponsor: AMNEAL PHARMS LLC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A211293-001	ESTRADIOL	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04
A211293-002	ESTRADIOL	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04
A211293-003	ESTRADIOL	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04
A211293-004	ESTRADIOL	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04
A211293-005	ESTRADIOL	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211293-001	AB1
A211293-002	AB1
A211293-003	AB1
A211293-004	AB1
A211293-005	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 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211293-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-004	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-005	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211293-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-005	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-004	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-005	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211293-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-004	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-005	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-004	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-005	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-004	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-005	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-004	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-005	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-004	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-005	AB1	1	`2680178bc6a6…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOTTI	ESTRADIOL	Bryant Ranch Prepack	75fc6d3a-49b6-47ad-b704-410692010d3a	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293
DOTTI	ESTRADIOL	Bryant Ranch Prepack	b119df4a-c514-4804-b1a8-b09c6058e80d	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293
DOTTI	ESTRADIOL	Bryant Ranch Prepack	f419192a-eb95-4087-9fe0-0eea639ef51b	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293
DOTTI	ESTRADIOL	Bryant Ranch Prepack	779751dc-243a-4dc2-ae67-3669f196b205	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293
DOTTI	ESTRADIOL	Bryant Ranch Prepack	99b889a0-6200-4727-97d3-f5a0b7814e1b	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293
Estradiol	ESTRADIOL	Amneal Pharmaceuticals NY LLC	0500ee9b-bf4a-4432-9afe-20a7d60a6fe5	2024-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293 ndc (product): 69238-1631 ndc (product): 69238-1630 ndc (product): 69238-1629 ndc (product): 69238-1633 ndc (product): 69238-1632
DOTTI	ESTRADIOL	Amneal Pharmaceuticals LLC	53016d30-6b5f-49da-ac16-85ef415a5805	2024-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293 ndc (product): 65162-992 ndc (product): 65162-997 ndc (product): 65162-989 ndc (product): 65162-993 ndc (product): 65162-995

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-989	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-989	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-989	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-992	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-992	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-992	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-993	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-993	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-993	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-995	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-995	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-995	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-997	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-997	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-997	DOTTI	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1629	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1629	Estradiol	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1629	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1629	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1630	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1630	Estradiol	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1630	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1630	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1631	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1631	Estradiol	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1631	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1631	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1632	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1632	Estradiol	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1632	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1632	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1633	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1633	Estradiol	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1633	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1633	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current