Application 208956

Type: NDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIPTODUR KIT	TRIPTORELIN PAMOATE	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	EQ 22.5MG BASE/VIAL	Yes	Yes

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
N208956-001	TRIPTODUR KIT	TRIPTORELIN PAMOATE	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2017-06-29

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208956-001	10166181	2029-06-30		Drug product	2019-01-25

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208956-001	TRIPTODUR KIT	EQ 22.5MG BASE/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2017-06-29	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208956-001	10166181	2029-02-10	Drug product	2019-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208956-001	10166181	2029-02-10	Drug product	2019-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208956-001	10166181	2029-02-10	Drug product	2019-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208956-001	10166181	2029-02-10	Drug product	2019-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208956-001	10166181	2029-06-30	Drug product	2019-01-25	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208956-001	ODE-149	2024-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208956-001	ODE-149	2024-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208956-001	ODE-149	2024-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208956-001	ODE-149	2024-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208956-001	ODE-149	2024-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208956-001	ODE-149	2024-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208956-001	ODE-149	2024-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208956-001	ODE-149	2024-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208956-001	ODE-149	2024-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208956-001	ODE-149	2024-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208956-001	ODE-149	2024-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208956-001	ODE-149	2024-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208956-001	NP	2020-06-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208956-001	ODE-149	2024-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208956-001	ODE-149	2024-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208956-001	ODE-149	2024-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208956-001	ODE-149	2024-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208956-001	ODE-149	2024-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208956-001	NP	2020-06-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208956-001	ODE-149	2024-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208956-001	NP	2020-06-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208956-001	ODE-149	2024-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208956-001	NP	2020-06-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208956-001	ODE-149	2024-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208956-001	NP	2020-06-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208956-001	ODE-149	2024-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208956-001	NP	2020-06-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208956-001	ODE-149	2024-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208956-001	ODE-149	2024-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208956-001	ODE-149	2024-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208956-001	ODE-149	2024-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208956-001	ODE-149	2024-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208956-001	ODE-149	2024-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208956-001	ODE-149	2024-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208956-001	ODE-149	2024-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208956-001	ODE-149	2024-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208956-001	ODE-149	2024-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208956-001	ODE-149	2024-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208956-001	ODE-149	2024-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208956-001	ODE-149	2024-06-29	`e64feba35796…`

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
TRIPTODUR	TRIPTORELIN	Azurity Pharmaceuticals, Inc.	f41380e7-b830-432d-a5f5-a872932f107e	2025-09-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208956 application number: NDA208956 ndc (product): 24338-150

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
24338-150	TRIPTODUR	triptorelin	Arbor Pharmaceuticals, LLC	NDA	Current
24338-150	TRIPTODUR	triptorelin	Arbor Pharmaceuticals, LLC	NDA	Current
24338-150	TRIPTODUR	triptorelin	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-150	TRIPTODUR	triptorelin	Arbor Pharmaceuticals, LLC	NDA	Current
24338-150	TRIPTODUR	triptorelin	Arbor Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83460	SUPPL	2025-09-25
83459	SUPPL	2025-09-25
83427	SUPPL	2025-09-24
72833	SUPPL	2022-12-09
72832	SUPPL	2022-12-09
72822	SUPPL	2022-12-08
70829	SUPPL	2022-04-27
70828	SUPPL	2022-04-27
70811	SUPPL	2022-04-26
60466	SUPPL	2019-10-09
52677	ORIG	2018-02-21
48900	ORIG	2017-07-05
48872	ORIG	2017-06-30
48911	ORIG	2017-06-29