Application 022074

Type: NDA
Sponsor: IPSEN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOMATULINE DEPOT	LANREOTIDE ACETATE	SOLUTION;SUBCUTANEOUS	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	Yes	Yes
002	SOMATULINE DEPOT	LANREOTIDE ACETATE	SOLUTION;SUBCUTANEOUS	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	Yes	Yes
003	SOMATULINE DEPOT	LANREOTIDE ACETATE	SOLUTION;SUBCUTANEOUS	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022074-001	SOMATULINE DEPOT	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30
N022074-002	SOMATULINE DEPOT	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30
N022074-003	SOMATULINE DEPOT	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022074-003	AB

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 4 of 4 · 132 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
2022-10-28 04:53 UTC	2022-10	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 49 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N022074-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022074-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022074-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022074-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022074-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022074-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022074-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022074-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022074-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022074-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022074-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022074-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022074-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022074-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022074-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022074-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022074-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022074-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022074-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022074-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022074-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022074-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022074-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022074-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022074-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022074-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022074-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022074-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022074-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022074-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022074-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022074-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022074-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022074-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022074-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022074-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022074-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022074-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022074-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022074-003	AB	1	`79d66fd596c7…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022074-001	5595760	2020-03-08	U-831	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022074-002	5595760	2020-03-08	U-831	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022074-003	5595760	2020-03-08	U-831	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022074-001	5595760	2020-03-08	U-831	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022074-002	5595760	2020-03-08	U-831	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022074-003	5595760	2020-03-08	U-831	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022074-001	5595760	2020-03-08	U-831	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022074-002	5595760	2020-03-08	U-831	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022074-003	5595760	2020-03-08	U-831	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022074-001	5595760	2020-03-08	U-831	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022074-002	5595760	2020-03-08	U-831	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022074-003	5595760	2020-03-08	U-831	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022074-001	5595760	2020-03-08	U-831	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022074-002	5595760	2020-03-08	U-831	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022074-003	5595760	2020-03-08	U-831	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022074-001	5595760	2020-03-08	U-831	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022074-002	5595760	2020-03-08	U-831	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022074-003	5595760	2020-03-08	U-831	Drug product	`ea99ee380514…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 150 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	N022074-001	ODE-156	2024-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022074-002	ODE-156	2024-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022074-003	ODE-156	2024-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022074-001	ODE-156	2024-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022074-002	ODE-156	2024-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022074-003	ODE-156	2024-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022074-001	ODE-156	2024-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022074-002	ODE-156	2024-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022074-003	ODE-156	2024-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022074-001	ODE-156	2024-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022074-002	ODE-156	2024-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022074-003	ODE-156	2024-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022074-001	ODE-156	2024-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022074-002	ODE-156	2024-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022074-003	ODE-156	2024-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022074-001	ODE-156	2024-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022074-002	ODE-156	2024-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022074-003	ODE-156	2024-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022074-001	ODE-156	2024-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022074-002	ODE-156	2024-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022074-003	ODE-156	2024-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022074-001	ODE-156	2024-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022074-002	ODE-156	2024-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022074-003	ODE-156	2024-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022074-001	ODE-156	2024-09-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022074-002	ODE-156	2024-09-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022074-003	ODE-156	2024-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022074-001	ODE-156	2024-09-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022074-002	ODE-156	2024-09-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022074-003	ODE-156	2024-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022074-001	ODE-156	2024-09-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022074-002	ODE-156	2024-09-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022074-003	ODE-156	2024-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022074-001	ODE-156	2024-09-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022074-002	ODE-156	2024-09-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022074-003	ODE-156	2024-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022074-001	I-754	2020-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022074-001	ODE-82	2021-12-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022074-001	ODE-156	2024-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022074-002	I-754	2020-09-15	`74a2ff9319b5…`

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
SOMATULINE DEPOT	LANREOTIDE ACETATE	Ipsen Biopharmaceuticals, Inc.	6e4a41fd-a753-4362-87ee-8cc56ed3660d	2024-10-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022074 application number: NDA022074 ndc (product): 15054-1060 ndc (product): 15054-1120 ndc (product): 15054-1090

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
15054-1060	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1060	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1060	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1060	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1060	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1090	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1090	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1090	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1090	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1090	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1120	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1120	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1120	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1120	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-1120	SOMATULINE DEPOT	lanreotide acetate	Ipsen Biopharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79087	SUPPL	2024-07-15
79066	SUPPL	2024-07-15
73609	SUPPL	2023-02-27
73608	SUPPL	2023-02-27
73142	SUPPL	2023-01-11
73139	SUPPL	2023-01-11
72844	SUPPL	2022-12-09
72839	SUPPL	2022-12-09
72414	SUPPL	2022-10-19
58320	SUPPL	2019-04-12
58307	SUPPL	2019-04-12
57151	SUPPL	2019-01-09
56860	SUPPL	2018-12-20
53728	SUPPL	2018-04-18
53719	SUPPL	2018-04-18
52723	SUPPL	2018-02-26
52695	SUPPL	2018-02-23
49779	SUPPL	2017-09-19
49775	SUPPL	2017-09-19
16900	SUPPL	2015-01-09
6829	SUPPL	2014-12-24
6830	SUPPL	2014-12-17
16901	SUPPL	2014-12-16
16898	SUPPL	2014-10-29
29207	SUPPL	2013-12-05
16899	SUPPL	2013-12-03
29206	SUPPL	2011-03-08
16897	SUPPL	2011-03-07
42409	ORIG	2007-11-06
29205	ORIG	2007-09-04
16896	ORIG	2007-09-04