Application 209767

Type: ANDA
Sponsor: ALVOGEN PINE BROOK

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 1.

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
A209767-001	ESTRADIOL	ESTRADIOL	0.01%	CREAM / VAGINAL	AB		2018-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209767-001	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 · 41 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	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A209767-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209767-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209767-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209767-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209767-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209767-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209767-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209767-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209767-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209767-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209767-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209767-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209767-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209767-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209767-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209767-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209767-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209767-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209767-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209767-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209767-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209767-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209767-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209767-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209767-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209767-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209767-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209767-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209767-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209767-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209767-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209767-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209767-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209767-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209767-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209767-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209767-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209767-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209767-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209767-001	AB	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Alvogen Inc.	0178a92c-62b1-d5cf-cf54-2c85af88a74a	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209767 application number: ANDA209767 ndc (product): 47781-104
ESTRADIOL VAGINAL	ESTRADIOL	Encube Ethicals, Inc.	1c61e837-4196-4b4d-9545-96b2d7c66f13	2025-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209767 application number: ANDA209767
Estradiol	ESTRADIOL	Bryant Ranch Prepack	74baff07-15df-48a8-93b8-3a317f896a56	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209767 application number: ANDA209767 ndc (product): 63629-8713
Estradiol	ESTRADIOL	A-S Medication Solutions	31646359-292c-4bca-88a4-7a89b11c3f44	2023-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209767 application number: ANDA209767 ndc (product): 50090-3645

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
47781-104	Estradiol	Estradiol	Alvogen Inc.	ANDA	Current
47781-104	Estradiol	Estradiol	Alvogen Inc.	ANDA	Current
47781-104	Estradiol	Estradiol	Alvogen Inc.	ANDA	Current
47781-104	Estradiol	Estradiol	Alvogen Inc.	ANDA	Current
47781-104	Estradiol	Estradiol	Alvogen Inc.	ANDA	Current
50090-3645	Estradiol	Estradiol	A-S Medication Solutions	ANDA	Current
50090-3645	Estradiol	Estradiol	A-S Medication Solutions	ANDA	Current
50090-3645	Estradiol	Estradiol	A-S Medication Solutions	ANDA	Current
63629-8713	Estradiol	Estradiol	Bryant Ranch Prepack	ANDA	Current
63629-8713	Estradiol	Estradiol	Bryant Ranch Prepack	ANDA	Current
63629-8713	Estradiol	Estradiol	Bryant Ranch Prepack	ANDA	Current