Application 206685

Type: ANDA
Sponsor: MYLAN TECHNOLOGIES

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
A206685-001	ESTRADIOL	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15
A206685-002	ESTRADIOL	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15
A206685-003	ESTRADIOL	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15
A206685-004	ESTRADIOL	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15
A206685-005	ESTRADIOL	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206685-001	AB3
A206685-002	AB3
A206685-003	AB3
A206685-004	AB3
A206685-005	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 6 · 205 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	A206685-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206685-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206685-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206685-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206685-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206685-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206685-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206685-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206685-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206685-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206685-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206685-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206685-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206685-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206685-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206685-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206685-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206685-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206685-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206685-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206685-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206685-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206685-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206685-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206685-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206685-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206685-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206685-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206685-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206685-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206685-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206685-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206685-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206685-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206685-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206685-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206685-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206685-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206685-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206685-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2018-08-15	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A206685-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206685-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206685-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206685-004	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206685-005	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206685-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206685-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206685-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206685-004	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206685-005	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206685-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206685-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206685-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206685-004	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206685-005	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206685-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206685-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206685-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206685-004	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206685-005	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206685-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206685-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206685-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206685-004	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206685-005	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206685-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206685-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206685-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206685-004	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206685-005	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206685-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206685-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206685-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206685-004	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206685-005	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206685-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206685-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206685-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206685-004	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206685-005	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	f4efb0bf-b96f-4e20-a0f2-0806ab92b2d4	2025-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206685 application number: ANDA206685 ndc (product): 0378-4620 ndc (product): 0378-4621 ndc (product): 0378-4622 ndc (product): 0378-4623 ndc (product): 0378-4619

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4619	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4619	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4619	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4620	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4620	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4620	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4621	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4621	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4621	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4622	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4622	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4622	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4623	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4623	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4623	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55408	ORIG	2018-09-07
55332	ORIG	2018-08-27