Application 022569

Type: NDA
Sponsor: BTCP PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAZANDA	FENTANYL CITRATE	SPRAY, METERED;NASAL	EQ 0.1MG BASE	Yes	No
002	LAZANDA	FENTANYL CITRATE	SPRAY, METERED;NASAL	EQ 0.4MG BASE	Yes	Yes
003	LAZANDA	FENTANYL CITRATE	SPRAY, METERED;NASAL	EQ 0.3MG BASE	Yes	No

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
N022569-001	LAZANDA	FENTANYL CITRATE	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30
N022569-002	LAZANDA	FENTANYL CITRATE	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30
N022569-003	LAZANDA	FENTANYL CITRATE	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21

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
N022569-001	9731869	2032-01-26	Drug product	2017-09-01
N022569-002	9731869	2032-01-26	Drug product	2017-09-01
N022569-003	9731869	2032-01-26	Drug product	2017-09-01

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UTC	2026-02	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022569-002	LAZANDA	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022569-003	LAZANDA	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022569-001	LAZANDA	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 438 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	N022569-001	9731869	2032-01-26		Drug product	2017-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022569-002	9731869	2032-01-26		Drug product	2017-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022569-003	9731869	2032-01-26		Drug product	2017-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022569-001	9731869	2032-01-26		Drug product	2017-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022569-002	9731869	2032-01-26		Drug product	2017-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022569-003	9731869	2032-01-26		Drug product	2017-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022569-001	9731869	2032-01-26		Drug product	2017-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022569-002	9731869	2032-01-26		Drug product	2017-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022569-003	9731869	2032-01-26		Drug product	2017-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022569-001	9731869	2032-01-26		Drug product	2017-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022569-002	9731869	2032-01-26		Drug product	2017-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022569-003	9731869	2032-01-26		Drug product	2017-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022569-001	9731869	2032-01-26		Drug product	2017-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022569-002	9731869	2032-01-26		Drug product	2017-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022569-003	9731869	2032-01-26		Drug product	2017-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-001	9078814	2024-01-08		Drug product	2015-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-001	9814705	2024-01-08		Drug product	2017-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-001	8889176	2024-01-16	U-767		2014-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-001	8216604	2024-10-03	U-767		2012-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-001	9731869	2032-01-26		Drug product	2017-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-002	9078814	2024-01-08		Drug product	2015-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-002	9814705	2024-01-08		Drug product	2017-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-002	8889176	2024-01-16	U-767		2014-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-002	8216604	2024-10-03	U-767			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-002	9731869	2032-01-26		Drug product	2017-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-003	9814705	2024-01-08		Drug product	2017-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022569-003	9731869	2032-01-26		Drug product	2017-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-001	9078814	2024-01-08		Drug product	2015-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-001	9814705	2024-01-08		Drug product	2017-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-001	8889176	2024-01-16	U-767		2014-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-001	8216604	2024-10-03	U-767		2012-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-001	9731869	2032-01-26		Drug product	2017-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-002	9078814	2024-01-08		Drug product	2015-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-002	9814705	2024-01-08		Drug product	2017-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-002	8889176	2024-01-16	U-767		2014-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-002	8216604	2024-10-03	U-767			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-002	9731869	2032-01-26		Drug product	2017-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-003	9814705	2024-01-08		Drug product	2017-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022569-003	9731869	2032-01-26		Drug product	2017-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022569-001	9078814	2024-01-08		Drug product	2015-08-11	`5bbf6a4d5a75…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENTANYL CITRATE	FENTANYL CITRATE	Hospira, Inc.	1ed25b2c-334e-4021-ada1-3396f07630dc	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Hikma Pharmaceuticals USA Inc.	ce5db1c2-feb1-4ad2-847a-d02e865bd47e	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	bfa8018a-4cbc-434b-e09e-782872b0340a	2026-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Teva Pharmaceuticals USA, Inc.	78221eab-66fd-4cd8-9c81-af52eb83671c	2026-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Civica, Inc.	aacf276b-e133-4199-ad3f-67b894744c04	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Phlow Corp.	58dcd3f7-e3d8-4929-a186-8f680a51ff11	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Hikma Pharmaceuticals USA Inc.	c5fcdcbd-1dd1-4ebf-aa0d-edfe845414b7	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Fresenius Kabi USA, LLC	0c10e465-4117-48ba-a454-23ccb7a3fcc7	2025-09-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Fresenius Kabi USA, LLC	38d0c14a-a0c1-44cc-a939-0304eb8037d6	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FENTANYL CITRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13913-009	Lazanda	fentanyl citrate	Depomed, Inc.	NDA	Current
13913-010	Lazanda	fentanyl citrate	Depomed, Inc.	NDA	Current
13913-013	Lazanda	fentanyl citrate	Depomed, Inc.	NDA	Current
51772-311	LAZANDA	Fentanyl Citrate	Archimedes Pharma US Inc.	NDA	Current
51772-314	LAZANDA	Fentanyl Citrate	Archimedes Pharma US Inc.	NDA	Current
71500-110	Lazanda	fentanyl	West Therapeutic Development LLC	NDA	Current
71500-110	Lazanda	fentanyl	West Therapeutic Development LLC	NDA	Current
71500-110	LAZANDA	fentanyl	West Therapeutic Development LLC	NDA	Current
71500-110	LAZANDA	fentanyl	West Therapeutic Development LLC	NDA	Current
71500-130	Lazanda	fentanyl	West Therapeutic Development LLC	NDA	Current
71500-130	Lazanda	fentanyl	West Therapeutic Development LLC	NDA	Current
71500-130	LAZANDA	fentanyl	West Therapeutic Development LLC	NDA	Current
71500-130	LAZANDA	fentanyl	West Therapeutic Development LLC	NDA	Current
71500-140	Lazanda	fentanyl	West Therapeutic Development LLC	NDA	Current
71500-140	Lazanda	fentanyl	West Therapeutic Development LLC	NDA	Current
71500-140	LAZANDA	fentanyl	West Therapeutic Development LLC	NDA	Current
71500-140	LAZANDA	fentanyl	West Therapeutic Development LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72849	SUPPL	2022-12-09
71842	SUPPL	2022-08-18
69496	SUPPL	2021-12-07
66625	SUPPL	2021-03-08
66624	SUPPL	2021-03-08
66567	SUPPL	2021-03-08
65767	SUPPL	2020-12-28
60496	SUPPL	2019-10-09
60495	SUPPL	2019-10-09
60447	SUPPL	2019-10-09
49715	SUPPL	2017-09-11
47684	SUPPL	2017-03-24
47634	SUPPL	2017-03-22
47633	SUPPL	2017-03-22
46382	SUPPL	2016-12-21
46330	SUPPL	2016-12-21
29870	SUPPL	2015-12-22
38852	SUPPL	2015-01-09
38851	SUPPL	2015-01-08
38850	SUPPL	2015-01-08
29869	SUPPL	2014-12-31
29868	SUPPL	2014-12-31
7552	SUPPL	2014-12-31
17723	SUPPL	2013-11-19
17722	SUPPL	2013-11-19
17721	SUPPL	2013-11-19
7551	SUPPL	2013-11-13
7550	SUPPL	2013-11-13
7549	SUPPL	2013-11-13
38849	SUPPL	2012-06-11
7548	SUPPL	2012-06-07
44779	ORIG	2012-04-16
42560	ORIG	2012-04-16
7547	SUPPL	2012-01-03
38848	SUPPL	2011-12-28
7546	SUPPL	2011-11-14
44511	ORIG	2011-07-08
17720	ORIG	2011-07-06
7545	ORIG	2011-07-06