Application 200677

Type: NDA
Sponsor: RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIGNIFOR	PASIREOTIDE DIASPARTATE	SOLUTION;SUBCUTANEOUS	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	Yes	No
002	SIGNIFOR	PASIREOTIDE DIASPARTATE	SOLUTION;SUBCUTANEOUS	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	Yes	No
003	SIGNIFOR	PASIREOTIDE DIASPARTATE	SOLUTION;SUBCUTANEOUS	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
N200677-001	SIGNIFOR	PASIREOTIDE DIASPARTATE	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14
N200677-002	SIGNIFOR	PASIREOTIDE DIASPARTATE	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14
N200677-003	SIGNIFOR	PASIREOTIDE DIASPARTATE	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10
N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10
N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10

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 4 · 123 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	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 240 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	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-002	8299209	2025-12-27	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-003	8299209	2025-12-27	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-002	8299209	2025-12-27	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-003	8299209	2025-12-27	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-002	8299209	2025-12-27	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-003	8299209	2025-12-27	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-002	8299209	2025-12-27	Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-003	8299209	2025-12-27	Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-002	8299209	2025-12-27	Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-003	8299209	2025-12-27	Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-002	8299209	2025-12-27	Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-003	8299209	2025-12-27	Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`5bbf6a4d5a75…`

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	N200677-001	ODE-34	2019-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200677-002	ODE-34	2019-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200677-003	ODE-34	2019-12-14	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N200677-001	ODE-34	2019-12-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200677-002	ODE-34	2019-12-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200677-003	ODE-34	2019-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200677-001	ODE-34	2019-12-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200677-002	ODE-34	2019-12-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200677-003	ODE-34	2019-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200677-001	ODE-34	2019-12-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200677-002	ODE-34	2019-12-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200677-003	ODE-34	2019-12-14	`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
Signifor	PASIREOTIDE	Recordati Rare Diseases, Inc.	a09a25fc-a5a3-0c82-e053-2995a90a5d74	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200677 application number: NDA200677 ndc (product): 55292-131 ndc (product): 55292-133 ndc (product): 55292-132

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0633	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0633	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0633	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0633	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0633	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0634	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0634	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0634	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0634	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0634	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0634	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0635	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0635	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0635	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0635	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0635	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0635	Signifor	pasireotide	Novartis Pharmaceuticals Corporation	NDA	Current
55292-131	Signifor	pasireotide	Recordati Rare Diseases, Inc.	NDA	Current
55292-131	Signifor	pasireotide	Recordati Rare Diseases, Inc.	NDA	Current
55292-131	Signifor	pasireotide	Recordati Rare Diseases, Inc.	NDA	Current
55292-132	Signifor	pasireotide	Recordati Rare Diseases, Inc.	NDA	Current
55292-132	Signifor	pasireotide	Recordati Rare Diseases, Inc.	NDA	Current
55292-132	Signifor	pasireotide	Recordati Rare Diseases, Inc.	NDA	Current
55292-133	Signifor	pasireotide	Recordati Rare Diseases, Inc.	NDA	Current
55292-133	Signifor	pasireotide	Recordati Rare Diseases, Inc.	NDA	Current
55292-133	Signifor	pasireotide	Recordati Rare Diseases, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79089	SUPPL	2024-07-15
79088	SUPPL	2024-07-15
61585	SUPPL	2020-01-16
61583	SUPPL	2020-01-16
61581	SUPPL	2020-01-16
58334	SUPPL	2019-04-15
58309	SUPPL	2019-04-12
58308	SUPPL	2019-04-12
57578	SUPPL	2019-02-13
57383	SUPPL	2019-01-30
52990	SUPPL	2018-03-15
52932	SUPPL	2018-03-13
40040	SUPPL	2015-03-19
32047	SUPPL	2015-03-18
9842	SUPPL	2013-02-15
43353	ORIG	2013-01-22
24387	ORIG	2013-01-22
9841	ORIG	2012-12-21
23473	ORIG	2012-12-18
40039	ORIG	2012-12-17