Application 208811

Type: ANDA
Sponsor: MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FULVESTRANT	FULVESTRANT	INJECTABLE;INTRAMUSCULAR	50MG/ML	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
A208811-001	FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR			2019-07-23

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.

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	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208811-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-07-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208811-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-07-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A208811-001	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208811-001	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208811-001	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208811-001	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208811-001	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208811-001	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208811-001	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208811-001	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208811-001	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208811-001	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208811-001	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208811-001	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208811-001	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208811-001	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208811-001	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208811-001	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208811-001	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208811-001	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208811-001	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208811-001	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208811-001	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208811-001	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208811-001	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208811-001	AO	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208811-001	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208811-001	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208811-001	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208811-001	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208811-001	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208811-001	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208811-001	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208811-001	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208811-001	AO	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208811-001	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208811-001	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208811-001	AO	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208811-001	AO	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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLIGAVYX	FULVESTRANT	Avyxa Pharma, LLC	e20d8ca3-8837-4003-8b01-1ebec342062a	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: FULVESTRANT
fulvestrant	FULVESTRANT	Sagent Pharmaceuticals	d5ae9e07-73b0-4063-a9e4-0ffc5614c2b8	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	GLENMARK PHARMACEUTICALS INC., USA	99cf8b69-4c23-4886-80e9-b23e348b5bd7	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	46086fe7-190d-4963-97bc-1fe22d36e6d2	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	Alembic Pharmaceuticals Inc.	b02915fe-6c44-48c1-aaeb-997ddc59a595	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	BluePoint Laboratories.	57352662-d2fa-4dce-828f-4c51e46e0b4d	2025-07-25	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	Eugia US LLC	80b6dfe6-449d-4e2f-af90-bfbf9b04163b	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	BluePoint Laboratories	bc7b4eac-3b63-53d2-e053-2995a90ad5e7	2025-06-24	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	Amneal Pharmaceuticals LLC	f36f19ad-f044-4dba-80b6-d074ddffcd86	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	Amneal Pharmaceuticals LLC	a51aa693-b433-4b2d-a71b-9ba029b10ce3	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
FULVESTRANT	FULVESTRANT	Accord Healthcare Inc.	b471eb51-488e-5312-e053-2a95a90a8116	2025-03-10	Warnings, Adverse reactions	Name fallback brand name: FULVESTRANT generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	Hikma Pharmaceuticals USA Inc.	306c283b-9abe-4985-856b-1957f1f3af8b	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	Athenex Pharmaceutical Division, LLC.	8ed06e0e-c17b-4c71-8d03-888bcde4a638	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
FULVESTRANT	FULVESTRANT	Zydus Pharmaceuticals USA Inc.	994edf79-20a5-4e3a-bb35-c4fe3e65acba	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: FULVESTRANT generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	Dr.Reddy's Laboratories Inc	2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682	2024-07-31	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	Meitheal Pharmaceuticals Inc	015fafb6-23f7-4566-9c23-386eee7b035d	2024-06-17	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
fulvestrant	FULVESTRANT	Sagent Pharmaceuticals	0f05b699-c440-42c1-9557-46759a10ab17	2024-03-22	Warnings, Adverse reactions	Name fallback brand name: fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	Avenacy, Inc.	f44cffcc-8f5e-4a4c-a36e-ab946ce86266	2024-02-28	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	Fresenius Kabi USA, LLC	fabe9bd8-ac23-4df1-a89a-223d5cd38914	2024-01-31	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT
Fulvestrant	FULVESTRANT	Sandoz Inc	7a03f714-b109-4256-80a6-78c82127d624	2022-09-21	Warnings, Adverse reactions	Name fallback brand name: Fulvestrant generic name: FULVESTRANT

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-311	Fulvestrant	Fulvestrant	Mylan Institutional LLC	ANDA	Current
67457-311	Fulvestrant	Fulvestrant	Mylan Institutional LLC	ANDA	Current
67457-311	Fulvestrant	Fulvestrant	Mylan Institutional LLC	ANDA	Current