Application 210194

Type: ANDA
Sponsor: PERRIGO UK FINCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTRADIOL	ESTRADIOL	CREAM;VAGINAL	0.01%	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210194-001	ESTRADIOL	ESTRADIOL	0.01%	CREAM / VAGINAL	AB		2018-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210194-001	AB

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 2 · 42 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	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A210194-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210194-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210194-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210194-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210194-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210194-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210194-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210194-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210194-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210194-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210194-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210194-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210194-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210194-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210194-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210194-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210194-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210194-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210194-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210194-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210194-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210194-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210194-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210194-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210194-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210194-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210194-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210194-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210194-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210194-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210194-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210194-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210194-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210194-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210194-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210194-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210194-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210194-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210194-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210194-001	AB	1	`e64feba35796…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol Vaginal	ESTRADIOL	Redpharm Drug	546c168d-2a85-69b6-e063-6294a90a22ac	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	A-S Medication Solutions	0137d491-6917-4060-9b32-e0cd7b0badbb	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	Bryant Ranch Prepack	67f581cb-6d77-49fc-b2f3-976e3b57dcbf	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	AvKARE	bb7b442d-b8c3-b7f0-e053-2a95a90a2c94	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194 ndc (product): 42291-426
Estradiol Vaginal	ESTRADIOL	Padagis Israel Pharmaceuticals Ltd	f76232ed-b109-43d1-bf2e-d41b6420c37d	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194 ndc (product): 45802-097
Estradiol Vaginal	ESTRADIOL	Bryant Ranch Prepack	f3806b5d-ebd6-43b4-adfa-a1fe86d80642	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	NuCare Pharmaceuticals, Inc.	2e5a4d78-6683-4fb8-e063-6294a90a49e7	2025-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	Bryant Ranch Prepack	e7b15ec3-e195-44a6-bdd7-9b6de2b235b8	2024-07-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194 ndc (product): 63629-8654

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1518	Estradiol Vaginal	Estradiol	Impax Generics	ANDA	Current
0115-1518	Estradiol Vaginal	Estradiol	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1518	Estradiol Vaginal	Estradiol	Amneal Pharmaceuticals of New York LLC	ANDA	Current
42291-426	Estradiol Vaginal	Estradiol	AvKARE	ANDA	Current
42291-426	Estradiol Vaginal	Estradiol	AvKARE	ANDA	Current
45802-097	Estradiol Vaginal	Estradiol	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-097	Estradiol Vaginal	Estradiol	Perrigo New York Inc	ANDA	Current
45802-097	Estradiol Vaginal	Estradiol	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
63629-8654	Estradiol Vaginal	Estradiol	Bryant Ranch Prepack	ANDA	Current
63629-8654	Estradiol Vaginal	Estradiol	Bryant Ranch Prepack	ANDA	Current
63629-8654	Estradiol Vaginal	Estradiol	Bryant Ranch Prepack	ANDA	Current