Application 201675

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
A201675-001	ESTRADIOL	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19
A201675-002	ESTRADIOL	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19
A201675-003	ESTRADIOL	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19
A201675-004	ESTRADIOL	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19
A201675-005	ESTRADIOL	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201675-001	AB1
A201675-002	AB1
A201675-003	AB1
A201675-004	AB1
A201675-005	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 · 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	A201675-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201675-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201675-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201675-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201675-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201675-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201675-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201675-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201675-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201675-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201675-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201675-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201675-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201675-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201675-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201675-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201675-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201675-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201675-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201675-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201675-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201675-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201675-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201675-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201675-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201675-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201675-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201675-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201675-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201675-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201675-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201675-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201675-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201675-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201675-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201675-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201675-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201675-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201675-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201675-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2014-12-19	`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	A201675-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201675-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201675-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201675-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201675-005	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201675-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201675-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201675-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201675-004	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201675-005	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201675-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201675-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201675-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201675-004	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201675-005	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201675-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201675-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201675-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201675-004	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201675-005	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201675-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201675-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201675-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201675-004	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201675-005	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201675-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201675-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201675-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201675-004	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201675-005	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201675-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201675-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201675-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201675-004	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201675-005	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201675-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201675-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201675-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201675-004	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201675-005	AB1	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.	d28bec8f-762e-4f05-a20d-96a42970d6a7	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201675 application number: ANDA201675 ndc (product): 0378-4644 ndc (product): 0378-4641 ndc (product): 0378-4640 ndc (product): 0378-4643 ndc (product): 0378-4642

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
0378-4640	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4640	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4640	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4641	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4641	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4641	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4642	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4642	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4642	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4643	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4643	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4643	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4644	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4644	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4644	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current