Application 021642

Type: NDA
Sponsor: ENDO PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NASCOBAL	CYANOCOBALAMIN	SPRAY, METERED;NASAL	0.5MG/SPRAY	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
N021642-001	NASCOBAL	CYANOCOBALAMIN	0.5MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2005-01-31

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021642-001	NASCOBAL	0.5MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2005-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021642-001	NASCOBAL	0.5MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2005-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021642-001	NASCOBAL	0.5MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2005-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021642-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021642-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021642-001	AB	1	`8072bd15b7f6…`
2020-11-12 02:37 UTC	2020-11	N021642-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021642-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021642-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021642-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021642-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021642-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021642-001	AB	1	`a67488948f0b…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	7404489	2024-03-12		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	7229636	2024-08-01	U-817	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	7879349	2024-08-01	U-1152	Drug product	2011-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	8003353	2024-08-01	U-817		2014-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	7404489	2024-03-12		Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	7229636	2024-08-01	U-817	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	7879349	2024-08-01	U-1152	Drug product	2011-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	8003353	2024-08-01	U-817		2014-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	7404489	2024-03-12		Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	7229636	2024-08-01	U-817	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	7879349	2024-08-01	U-1152	Drug product	2011-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	8003353	2024-08-01	U-817		2014-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	7404489	2024-03-12		Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	7229636	2024-08-01	U-817	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	7879349	2024-08-01	U-1152	Drug product	2011-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	8003353	2024-08-01	U-817		2014-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021642-001	7404489	2024-03-12		Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021642-001	7229636	2024-08-01	U-817	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021642-001	7879349	2024-08-01	U-1152	Drug product	2011-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021642-001	8003353	2024-08-01	U-817		2014-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	7404489	2024-03-12		Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	7229636	2024-08-01	U-817	Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	7879349	2024-08-01	U-1152	Drug product	2011-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	8003353	2024-08-01	U-817		2014-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021642-001	7404489	2024-03-12		Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021642-001	7229636	2024-08-01	U-817	Drug product		`301d65b070ca…`

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
Nascobal	CYANOCOBALAMIN	Par Health USA, LLC	697e0e52-c01b-4b53-9994-f79c46eb6b4f	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021642 application number: NDA021642 ndc (product): 49884-270

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-270	Nascobal	cyanocobalamin	Par Pharmaceutical, Inc.	NDA	Current
49884-270	Nascobal	cyanocobalamin	Par Pharmaceutical, Inc.	NDA	Current
49884-270	Nascobal	cyanocobalamin	Par Pharmaceutical, Inc.	NDA	Current
49884-270	Nascobal	cyanocobalamin	Par Pharmaceutical, Inc.	NDA	Current
49884-270	Nascobal	cyanocobalamin	Par Pharmaceutical, Inc.	NDA	Current
49884-270	Nascobal	cyanocobalamin	Par Pharmaceutical , Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56829	SUPPL	2018-12-20
56756	SUPPL	2018-12-17
48859	SUPPL	2017-06-29
15915	SUPPL	2014-06-10
37388	SUPPL	2014-02-07
28301	SUPPL	2014-02-07
28300	SUPPL	2006-09-20
37387	SUPPL	2006-09-18
42247	ORIG	2006-06-16
28299	ORIG	2005-02-03
15914	ORIG	2005-02-03