Application 210044

Type: ANDA
Sponsor: AMNEAL

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
A210044-001	FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO		2019-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210044-001	AO

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	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210044-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210044-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-03-04	`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	A210044-001	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210044-001	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210044-001	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210044-001	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210044-001	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210044-001	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210044-001	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210044-001	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210044-001	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210044-001	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210044-001	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210044-001	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210044-001	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210044-001	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210044-001	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210044-001	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210044-001	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210044-001	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210044-001	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210044-001	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210044-001	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210044-001	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210044-001	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210044-001	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210044-001	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210044-001	AO	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210044-001	AO	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210044-001	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210044-001	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210044-001	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210044-001	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210044-001	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210044-001	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210044-001	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210044-001	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210044-001	AO	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210044-001	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210044-001	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210044-001	AO	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210044-001	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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fulvestrant	FULVESTRANT	BluePoint Laboratories	bc7b4eac-3b63-53d2-e053-2995a90ad5e7	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210044 application number: ANDA210044 ndc (product): 68001-484
Fulvestrant	FULVESTRANT	Amneal Pharmaceuticals LLC	f36f19ad-f044-4dba-80b6-d074ddffcd86	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210044 application number: ANDA210044 ndc (product): 70121-1463
Fulvestrant	FULVESTRANT	Amneal Pharmaceuticals LLC	a51aa693-b433-4b2d-a71b-9ba029b10ce3	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210044 application number: ANDA210044 ndc (product): 70121-1463

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68001-484	Fulvestrant	Fulvestrant	BluePoint Laboratories	ANDA	Current
70121-1463	Fulvestrant	Fulvestrant	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1463	Fulvestrant	Fulvestrant	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1463	Fulvestrant	Fulvestrant	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1463	Fulvestrant	Fulvestrant	Amneal Biosciences LLC	ANDA	Current
70121-1463	Fulvestrant	Fulvestrant	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1463	Fulvestrant	Fulvestrant	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1463	Fulvestrant	Fulvestrant	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1463	Fulvestrant	Fulvestrant	Amneal Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58424	ORIG	2019-04-26