Application 021224

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RAZADYNE	GALANTAMINE HYDROBROMIDE	SOLUTION;ORAL	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

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
N021224-001	RAZADYNE	GALANTAMINE HYDROBROMIDE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL			2001-06-22

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021224-001	RAZADYNE	4MG/ML	SOLUTION / ORAL	2001-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021224-001	RAZADYNE	4MG/ML	SOLUTION / ORAL	2001-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	2001-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	2001-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	2001-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	2001-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	2001-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	2001-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	2001-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	2001-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	2001-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021224-001	RAZADYNE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	2001-06-22	`cb3db0bc1861…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Bryant Ranch Prepack	0f74a146-f6ee-4910-82a3-177153526dd0	2025-09-12	Warnings, Adverse reactions	Name fallback generic name: GALANTAMINE HYDROBROMIDE
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Bryant Ranch Prepack	3059d10f-fb3d-4cbd-b936-104608889b67	2024-08-12	Warnings, Adverse reactions	Name fallback generic name: GALANTAMINE HYDROBROMIDE
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Bryant Ranch Prepack	db5b6c1e-449b-413f-b0cc-ca2133aa4986	2024-08-12	Warnings, Adverse reactions	Name fallback generic name: GALANTAMINE HYDROBROMIDE
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Bryant Ranch Prepack	3e7e2839-a834-4464-a82a-7554e10ad004	2024-08-12	Warnings, Adverse reactions	Name fallback generic name: GALANTAMINE HYDROBROMIDE
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Bryant Ranch Prepack	5cd99bc0-0f18-4800-a0f5-a94eebf0eead	2024-04-08	Warnings, Adverse reactions	Name fallback generic name: GALANTAMINE HYDROBROMIDE
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Bryant Ranch Prepack	c44108aa-bf20-4d45-b36f-d117320a675b	2024-04-08	Warnings, Adverse reactions	Name fallback generic name: GALANTAMINE HYDROBROMIDE
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Sun Pharmaceutical Industries, Inc.	d1697161-ebe8-42b0-83e7-c9de4412546c	2023-10-26	Warnings, Adverse reactions	Name fallback generic name: GALANTAMINE HYDROBROMIDE
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Hikma Pharmaceuticals USA Inc.	d5b0e225-e94d-4324-afb2-b6e51c949dd0	2023-10-25	Warnings, Adverse reactions	Name fallback generic name: GALANTAMINE HYDROBROMIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47241	SUPPL	2017-02-16
47238	SUPPL	2017-02-16
27112	SUPPL	2015-12-17
14665	SUPPL	2015-12-17
4676	SUPPL	2015-02-12
36385	SUPPL	2015-02-10
14664	SUPPL	2013-07-11
4674	SUPPL	2013-07-02
36384	SUPPL	2012-05-01
36383	SUPPL	2012-03-06
14663	SUPPL	2012-03-06
27111	SUPPL	2012-03-05
4675	SUPPL	2012-03-05
4673	SUPPL	2012-03-05
27110	SUPPL	2006-05-01
27109	SUPPL	2006-05-01
4672	SUPPL	2006-05-01
4671	SUPPL	2006-05-01
23635	ORIG	2005-07-29
4670	SUPPL	2005-05-03
4669	SUPPL	2003-09-09
4668	SUPPL	2002-05-02
21518	ORIG	2002-03-05
14662	ORIG	2001-06-22
4667	ORIG	2001-06-22