Application 021344

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FASLODEX	FULVESTRANT	INJECTABLE;INTRAMUSCULAR	50MG/ML	Yes	Yes
002	FASLODEX	FULVESTRANT	SOLUTION;INTRAMUSCULAR	125MG/2.5ML (50MG/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021344-001	FASLODEX	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25
N021344-002	FASLODEX	FULVESTRANT	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021344-001	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 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021344-001	FASLODEX	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021344-002	FASLODEX	125MG/2.5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	2002-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021344-001	FASLODEX	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021344-001	FASLODEX	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021344-001	FASLODEX	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021344-001	FASLODEX	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021344-001	FASLODEX	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021344-001	FASLODEX	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021344-001	FASLODEX	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021344-001	FASLODEX	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	RLD, RS	2002-04-25	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N021344-001	AO	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021344-001	AO	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021344-001	AO	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 216 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021344-001	6774122	2021-01-09	U-2163			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	6774122	2021-01-09	U-2108			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	6774122	2021-01-09	U-2504			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	6774122	2021-01-09	U-596			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	6774122	2021-01-09	U-1826			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	7456160	2021-01-09	U-2163			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	7456160	2021-01-09	U-2108			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	7456160	2021-01-09	U-1826			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	7456160	2021-01-09	U-596			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	7456160	2021-01-09	U-2504			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	8329680	2021-01-09	U-2163		2013-01-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	8329680	2021-01-09	U-2504		2013-01-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	8329680	2021-01-09	U-1826		2013-01-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	8329680	2021-01-09	U-2108		2013-01-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	8329680	2021-01-09	U-596		2013-01-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	8466139	2021-01-09	U-1826			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	8466139	2021-01-09	U-2504			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	8466139	2021-01-09	U-2163			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	8466139	2021-01-09	U-596			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	8466139	2021-01-09	U-2108			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	6774122*PED	2021-07-09		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	7456160*PED	2021-07-09		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	8329680*PED	2021-07-09		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	8466139*PED	2021-07-09		Pediatric extension		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021344-001	6774122	2021-01-09	U-2108			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	6774122	2021-01-09	U-2504			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	6774122	2021-01-09	U-596			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	6774122	2021-01-09	U-1826			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	6774122	2021-01-09	U-2163			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	7456160	2021-01-09	U-2163			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	7456160	2021-01-09	U-2108			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	7456160	2021-01-09	U-1826			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	7456160	2021-01-09	U-596			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	7456160	2021-01-09	U-2504			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	8329680	2021-01-09	U-2163		2013-01-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	8329680	2021-01-09	U-2504		2013-01-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	8329680	2021-01-09	U-1826		2013-01-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	8329680	2021-01-09	U-2108		2013-01-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	8329680	2021-01-09	U-596		2013-01-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021344-001	8466139	2021-01-09	U-2504			`782e0a99824c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021344-001	I-725	2019-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021344-001	I-749	2020-08-25	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021344-001	I-749	2020-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021344-001	I-749	2020-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021344-001	I-725	2019-02-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021344-001	I-749	2020-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021344-001	I-725	2019-02-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021344-001	I-749	2020-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021344-001	I-725	2019-02-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021344-001	I-749	2020-08-25	`ea99ee380514…`

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
FASLODEX	FULVESTRANT	AstraZeneca Pharmaceuticals LP	83d7a440-e904-4e36-afb5-cb02b1c919f7	2020-09-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021344 application number: NDA021344 ndc (product): 0310-0720

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-0720	FASLODEX	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0720	FASLODEX	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0720	FASLODEX	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0720	FASLODEX	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0720	FASLODEX	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0720	FASLODEX	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0720	FASLODEX	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0720	FASLODEX	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0720	FASLODEX	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0720	FASLODEX	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-7720	Fulvestrant	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-7720	Fulvestrant	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-7720	Fulvestrant	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-7720	Fulvestrant	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-7720	Fulvestrant	Fulvestrant	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65952	SUPPL	2021-01-21
65946	SUPPL	2021-01-21
64131	SUPPL	2020-07-30
64121	SUPPL	2020-07-29
62994	SUPPL	2020-05-14
62975	SUPPL	2020-05-13
61030	SUPPL	2019-11-22
61016	SUPPL	2019-11-22
60035	SUPPL	2019-09-23
60058	SUPPL	2019-09-20
60055	SUPPL	2019-09-20
58828	SUPPL	2019-05-22
58819	SUPPL	2019-05-21
57966	SUPPL	2019-03-12
57964	SUPPL	2019-03-12
54914	SUPPL	2018-07-19
54777	SUPPL	2018-07-06
52788	SUPPL	2018-03-01
52653	SUPPL	2018-02-15
50420	SUPPL	2017-11-15
50412	SUPPL	2017-11-15
49557	SUPPL	2017-08-28
49551	SUPPL	2017-08-28
46995	SUPPL	2017-01-27
45731	SUPPL	2016-10-31
15232	SUPPL	2016-07-13
5103	SUPPL	2016-07-13
36707	SUPPL	2016-05-23
5102	SUPPL	2016-05-20
15231	SUPPL	2016-03-04
5101	SUPPL	2016-03-04
36706	SUPPL	2016-03-03
5100	SUPPL	2016-03-03
27535	SUPPL	2012-11-13
5099	SUPPL	2012-11-13
36705	SUPPL	2012-11-08
15230	SUPPL	2012-11-08
15229	SUPPL	2012-07-25
27534	SUPPL	2012-07-17
27533	SUPPL	2011-09-29
5098	SUPPL	2011-09-29
36704	SUPPL	2011-09-26
36703	SUPPL	2011-09-26
15228	SUPPL	2011-05-23
27532	SUPPL	2011-05-19
51928	SUPPL	2011-02-01
51927	SUPPL	2011-02-01
51926	SUPPL	2011-02-01
51925	SUPPL	2011-02-01
51924	SUPPL	2011-02-01
51923	SUPPL	2011-02-01
5097	SUPPL	2010-09-13
5096	SUPPL	2010-09-13
15227	SUPPL	2010-09-10
15226	SUPPL	2010-09-10
36702	SUPPL	2005-08-08
27531	SUPPL	2005-08-08
36701	SUPPL	2004-01-15
5095	SUPPL	2004-01-14
42113	ORIG	2002-04-25
36700	ORIG	2002-04-25
27530	ORIG	2002-04-25