Application 019726

Type: NDA
Sponsor: TERSERA THERAPS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLADEX	GOSERELIN ACETATE	IMPLANT;IMPLANTATION	EQ 3.6MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N019726-001	ZOLADEX	GOSERELIN ACETATE	EQ 3.6MG BASE	IMPLANT / IMPLANTATION		RLD, RS	1989-12-29

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N019726-001	ZOLADEX	EQ 3.6MG BASE	IMPLANT / IMPLANTATION	RLD, RS	1989-12-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019726-001	ZOLADEX	EQ 3.6MG BASE	IMPLANT / IMPLANTATION	RLD, RS	1989-12-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019726-001	ZOLADEX	EQ 3.6MG BASE	IMPLANT / IMPLANTATION	RLD, RS	1989-12-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019726-001	ZOLADEX	EQ 3.6MG BASE	IMPLANT / IMPLANTATION	RLD, RS	1989-12-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019726-001	7220247	2022-04-09	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019726-001	7118552	2022-04-13	Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019726-001	7220247	2022-04-09	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019726-001	7118552	2022-04-13	Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019726-001	7220247	2022-04-09	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019726-001	7118552	2022-04-13	Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019726-001	7500964	2021-02-26	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019726-001	7220247	2022-04-09	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019726-001	7118552	2022-04-13	Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019726-001	7220247	2022-04-09	Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019726-001	7118552	2022-04-13	Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019726-001	7500964	2021-02-26	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019726-001	7220247	2022-04-09	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019726-001	7118552	2022-04-13	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019726-001	7500964	2021-02-26	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019726-001	7220247	2022-04-09	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019726-001	7118552	2022-04-13	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019726-001	7500964	2021-02-26	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019726-001	7220247	2022-04-09	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019726-001	7118552	2022-04-13	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019726-001	7500964	2021-02-26	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019726-001	7220247	2022-04-09	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019726-001	7118552	2022-04-13	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019726-001	7500964	2021-02-26	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019726-001	7220247	2022-04-09	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019726-001	7118552	2022-04-13	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019726-001	7500964	2021-02-26	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019726-001	7220247	2022-04-09	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019726-001	7118552	2022-04-13	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019726-001	7500964	2021-02-26	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019726-001	7220247	2022-04-09	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019726-001	7118552	2022-04-13	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019726-001	7500964	2021-02-26	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019726-001	7220247	2022-04-09	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019726-001	7118552	2022-04-13	Drug product	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N019726-001	7220247	2022-04-09	Drug product	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019726-001	7118552	2022-04-13	Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019726-001	7220247	2022-04-09	Drug product	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019726-001	7118552	2022-04-13	Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019726-001	7220247	2022-04-09	Drug product	`f41ea6bd6efb…`

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
ZOLADEX	GOSERELIN	TerSera Therapeutics LLC	294b168b-6e5f-4db9-bf70-d599271458b3	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019726 application number: NDA019726 ndc (product): 70720-950

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-0950	ZOLADEX	Goserelin acetate	AstraZeneca Pharmaceuticals LP	NDA	Current
50090-2027	ZOLADEX	Goserelin acetate	A-S Medication Solutions	NDA	Current
50090-3466	ZOLADEX	goserelin acetate	A-S Medication Solutions	NDA	Current
50090-3466	ZOLADEX	goserelin acetate	A-S Medication Solutions	NDA	Current
50090-3466	ZOLADEX	goserelin acetate	A-S Medication Solutions	NDA	Current
70720-950	ZOLADEX	goserelin acetate	TerSera Therapeutics LLC	NDA	Current
70720-950	ZOLADEX	goserelin acetate	TerSera Therapeutics LLC	NDA	Current
70720-950	ZOLADEX	goserelin acetate	TerSera Therapeutics LLC	NDA	Current
70720-950	ZOLADEX	goserelin	TerSera Therapeutics LLC	NDA	Current
70720-950	ZOLADEX	goserelin	TerSera Therapeutics LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85883	SUPPL	2026-05-12
85848	SUPPL	2026-05-08
83590	SUPPL	2025-09-30
83587	SUPPL	2025-09-30
73793	SUPPL	2023-03-17
73789	SUPPL	2023-03-17
67852	SUPPL	2021-06-22
1548	SUPPL	2015-02-17
11657	SUPPL	2015-02-13
33891	SUPPL	2014-10-09
1547	SUPPL	2014-10-09
19125	SUPPL	2013-06-20
1546	SUPPL	2013-06-20
33890	SUPPL	2013-06-17
11656	SUPPL	2013-06-17
23551	ORIG	2011-12-20
11655	SUPPL	2011-01-20
1545	SUPPL	2011-01-20
19124	SUPPL	2010-01-07
1544	SUPPL	2010-01-07
1543	SUPPL	2010-01-07
33889	SUPPL	2009-09-17
11654	SUPPL	2009-09-17
11653	SUPPL	2009-09-17
1542	SUPPL	2005-10-25
19123	SUPPL	2004-06-25
19122	SUPPL	2002-02-28
40984	SUPPL	2002-02-05
19121	SUPPL	2002-02-05
40983	SUPPL	1998-07-27
33888	SUPPL	1998-07-27
19120	SUPPL	1998-07-27
20302	SUPPL	1998-04-09
20301	SUPPL	1997-06-27