Application 210326

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FULVESTRANT	FULVESTRANT	SOLUTION;INTRAMUSCULAR	250MG/5ML (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
N210326-001	FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO		2019-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N210326-001	AO

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19
N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19
N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19

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	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210326-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		2019-05-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210326-001	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210326-001	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210326-001	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210326-001	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210326-001	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210326-001	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210326-001	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210326-001	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210326-001	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210326-001	AO	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210326-001	AO	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210326-001	9833459	2034-02-14	U-2540	Drug product	2019-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210326-001	9271990	2034-05-17	U-2540	Drug product	2019-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210326-001	10188663	2034-02-14	U-2540	Drug product	2019-06-19	`8072bd15b7f6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fulvestrant	FULVESTRANT	Fresenius Kabi USA, LLC	fabe9bd8-ac23-4df1-a89a-223d5cd38914	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210326 application number: NDA210326 ndc (product): 63323-715

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-715	Fulvestrant	Fulvestrant	Fresenius Kabi USA, LLC	NDA	Current
63323-715	Fulvestrant	Fulvestrant	Fresenius Kabi USA, LLC	NDA	Current
63323-715	Fulvestrant	Fulvestrant	Fresenius Kabi USA, LLC	NDA	Current
63323-715	Fulvestrant	Fulvestrant	Fresenius Kabi USA, LLC	NDA	Current
63323-715	Fulvestrant	Fulvestrant	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67487	SUPPL	2021-05-13
67486	SUPPL	2021-05-13
67480	SUPPL	2021-05-13
67479	SUPPL	2021-05-13
61776	ORIG	2020-02-04
54823	ORIG	2019-10-22
58818	ORIG	2019-05-21