Application 211396

Type: ANDA
Sponsor: AMNEAL PHARMS

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 1.

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
A211396-001	ESTRADIOL	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28
A211396-002	ESTRADIOL	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28
A211396-003	ESTRADIOL	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28
A211396-004	ESTRADIOL	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28
A211396-005	ESTRADIOL	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211396-001	AB3
A211396-002	AB3
A211396-003	AB3
A211396-004	AB3
A211396-005	AB3

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 · 185 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
2026-02-19 14:30 UTC	2026-02	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 185 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211396-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-004	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-005	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-004	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-005	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211396-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-004	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-005	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-004	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-005	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-004	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-005	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-004	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-005	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-004	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-005	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-004	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-005	AB3	1	`5bbf6a4d5a75…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Amneal Pharmaceuticals NY LLC	d4259bb8-91f8-4587-8ceb-35d44145aec0	2024-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211396 application number: ANDA211396 ndc (product): 69238-1296 ndc (product): 69238-1293 ndc (product): 69238-1294 ndc (product): 69238-1447 ndc (product): 69238-1295
LYLLANA	ESTRADIOL	Amneal Pharmaceuticals LLC	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	2024-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211396 application number: ANDA211396 ndc (product): 65162-150 ndc (product): 65162-228 ndc (product): 65162-148 ndc (product): 65162-149 ndc (product): 65162-126

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
65162-126	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-126	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-126	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-126	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-126	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-148	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-148	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-148	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-148	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-148	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-149	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-149	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-149	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-149	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-149	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-150	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-150	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-150	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-150	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-150	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-228	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-228	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-228	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-228	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-228	LYLLANA	Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1293	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1293	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1294	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1294	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1295	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1295	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1296	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1296	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1447	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1447	Estradiol	Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current