Application 075182

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	0.1MG/24HR	No	No
002	ESTRADIOL	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.075MG/24HR	No	No
003	ESTRADIOL	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.025MG/24HR	No	No
004	ESTRADIOL	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.0375MG/24HR	No	No
005	ESTRADIOL	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.06MG/24HR	No	No
006	ESTRADIOL	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075182-001	ESTRADIOL	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24
A075182-002	ESTRADIOL	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26
A075182-003	ESTRADIOL	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26
A075182-004	ESTRADIOL	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20
A075182-005	ESTRADIOL	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20
A075182-006	ESTRADIOL	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A075182-001	AB2
A075182-002	AB2
A075182-003	AB2
A075182-004	AB2
A075182-005	AB2
A075182-006	AB2

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 7 · 246 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	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A075182-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-005	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-006	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-005	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-006	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075182-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-005	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-006	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-005	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-006	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-005	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-006	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075182-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075182-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075182-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075182-004	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075182-005	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075182-006	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075182-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075182-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075182-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075182-004	AB2	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
Estradiol	ESTRADIOL	A-S Medication Solutions	34bcec8e-c7a6-4a1c-9884-4d4efe024bb9	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182
Estradiol	ESTRADIOL	A-S Medication Solutions	ba935918-39b3-4b56-bd83-78a29958e6d8	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182
Estradiol	ESTRADIOL	A-S Medication Solutions	1c38f0d0-a360-4b66-bc0e-7d54e92465a1	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182
Estradiol	ESTRADIOL	A-S Medication Solutions	eacafc4a-2fa8-403d-8df7-2bc92d73a54f	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182
Estradiol	ESTRADIOL	A-S Medication Solutions	ee5460ab-27e7-487a-a89c-bf8735399be6	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182
Estradiol	ESTRADIOL	A-S Medication Solutions	e962e36d-5d84-4b39-9bdf-e5f9a264b82a	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	e7e6da3b-8485-1382-61c9-e9b369018b98	2025-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182 ndc (product): 0378-3350 ndc (product): 0378-3349 ndc (product): 0378-3351 ndc (product): 0378-3352 ndc (product): 0378-3361 ndc (product): 0378-3360

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3349	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3349	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3350	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3350	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3351	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3351	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3352	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3352	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3360	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3360	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3361	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3361	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30786	SUPPL	2006-07-21
8553	SUPPL	2006-07-21
22438	ORIG	2000-02-24
8552	ORIG	2000-02-24