Application 213224

Type: NDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BYNFEZIA PEN	OCTREOTIDE ACETATE	SOLUTION;SUBCUTANEOUS	EQ 2.5MG BASE/ML (EQ 2.5MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213224-001	BYNFEZIA PEN	OCTREOTIDE ACETATE	EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2024-09-27

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213224-001	10342850	2038-05-15		Drug product	2024-10-18
N213224-001	11052196	2040-11-03	U-4007		2024-10-18
N213224-001	11052196	2040-11-03	U-4008		2024-10-18
N213224-001	11052196	2040-11-03	U-4009		2024-10-18
N213224-001	11246991	2040-11-03	U-4007		2024-10-18
N213224-001	11246991	2040-11-03	U-4008		2024-10-18
N213224-001	11246991	2040-11-03	U-4009		2024-10-18
N213224-001	11534553	2040-11-03	U-4007		2024-10-18
N213224-001	11534553	2040-11-03	U-4008		2024-10-18
N213224-001	11534553	2040-11-03	U-4009		2024-10-18
N213224-001	12350475	2041-12-29	U-4007		2025-07-23
N213224-001	12350475	2041-12-29	U-4008		2025-07-23
N213224-001	12350475	2041-12-29	U-4009		2025-07-23

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.

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	N213224-001	BYNFEZIA PEN	EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	BYNFEZIA PEN	EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213224-001	BYNFEZIA PEN	EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213224-001	BYNFEZIA PEN	EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213224-001	BYNFEZIA PEN	EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213224-001	BYNFEZIA PEN	EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213224-001	BYNFEZIA PEN	EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-09-27	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213224-001	BYNFEZIA PEN	7MG/2.8ML (2.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213224-001	BYNFEZIA PEN	7MG/2.8ML (2.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-09-27	`d06236e962d9…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213224-001	BYNFEZIA PEN	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213224-001	BYNFEZIA PEN	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213224-001	BYNFEZIA PEN	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213224-001	BYNFEZIA PEN	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-01-28	`c0c555d07b60…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213224-001	BYNFEZIA PEN	EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-09-27	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 107 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213224-001	10342850	2038-05-15		Drug product	2024-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213224-001	11052196	2040-11-03	U-4007		2024-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213224-001	11052196	2040-11-03	U-4008		2024-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213224-001	11052196	2040-11-03	U-4009		2024-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213224-001	11246991	2040-11-03	U-4007		2024-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213224-001	11246991	2040-11-03	U-4008		2024-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213224-001	11246991	2040-11-03	U-4009		2024-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213224-001	11534553	2040-11-03	U-4007		2024-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213224-001	11534553	2040-11-03	U-4008		2024-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213224-001	11534553	2040-11-03	U-4009		2024-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213224-001	12350475	2041-12-29	U-4007		2025-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213224-001	12350475	2041-12-29	U-4008		2025-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213224-001	12350475	2041-12-29	U-4009		2025-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	10342850	2038-05-15		Drug product	2024-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	11052196	2040-11-03	U-4007		2024-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	11052196	2040-11-03	U-4008		2024-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	11052196	2040-11-03	U-4009		2024-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	11246991	2040-11-03	U-4007		2024-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	11246991	2040-11-03	U-4008		2024-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	11246991	2040-11-03	U-4009		2024-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	11534553	2040-11-03	U-4007		2024-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	11534553	2040-11-03	U-4008		2024-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	11534553	2040-11-03	U-4009		2024-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	12350475	2041-12-29	U-4007		2025-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	12350475	2041-12-29	U-4008		2025-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213224-001	12350475	2041-12-29	U-4009		2025-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213224-001	10342850	2038-05-15		Drug product	2024-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213224-001	11052196	2040-11-03	U-4007		2024-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213224-001	11052196	2040-11-03	U-4008		2024-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213224-001	11052196	2040-11-03	U-4009		2024-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213224-001	11246991	2040-11-03	U-4007		2024-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213224-001	11246991	2040-11-03	U-4008		2024-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213224-001	11246991	2040-11-03	U-4009		2024-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213224-001	11534553	2040-11-03	U-4007		2024-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213224-001	11534553	2040-11-03	U-4008		2024-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213224-001	11534553	2040-11-03	U-4009		2024-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213224-001	12350475	2041-12-29	U-4007		2025-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213224-001	12350475	2041-12-29	U-4008		2025-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213224-001	12350475	2041-12-29	U-4009		2025-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213224-001	10342850	2038-05-15		Drug product	2024-10-18	`fd3edfee7708…`

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
BYNFEZIA Pen	OCTREOTIDE ACETATE	Sun Pharmaceutical Industries, Inc.	20ed4e79-ad4c-426f-859d-83790c00439b	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213224 application number: NDA213224 ndc (product): 62756-452

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62756-452	BYNFEZIA Pen	octreotide acetate	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83095	ORIG	2025-08-12
79785	ORIG	2024-10-01
79780	ORIG	2024-09-30
63373	ORIG	2020-06-01
61733	ORIG	2020-01-29
61732	ORIG	2020-01-29