Application 204054

Type: ANDA
Sponsor: NEXGEN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MECAMYLAMINE HYDROCHLORIDE	MECAMYLAMINE HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A204054-001	MECAMYLAMINE HYDROCHLORIDE	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL		RS	2013-03-19

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204054-001	MECAMYLAMINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	RS	2013-03-19	`f41ea6bd6efb…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vecamyl	MECAMYLAMINE HYDROCHLORIDE	TILDE Sciences LLC	0b149023-f7a8-442d-ac69-295df8e66ed3	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204054 application number: ANDA204054
Vecamyl	MECAMYLAMINE HYDROCHLORIDE	Vyera Pharmaceuticals, LLC	0774cc48-7287-4093-91d6-9df41a81408a	2022-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204054 application number: ANDA204054 ndc (product): 69413-558

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0722-7183	Mecamylamine Hydrochloride	Mecamylamine Hydrochloride	Nexgen Pharma, Inc.	ANDA	Current
0722-7183	Mecamylamine Hydrochloride	Mecamylamine Hydrochloride	Nexgen Pharma, Inc.	ANDA	Current
45043-558	Vecamyl	Mecamylamine Hydrochloride	Manchester Pharmaceuticals	ANDA	Current
69413-558	Vecamyl	Mecamylamine Hydrochloride	Vyera Pharmaceuticals, LLC	ANDA	Current
69413-558	Vecamyl	Mecamylamine Hydrochloride	Vyera Pharmaceuticals, LLC	ANDA	Current
69413-558	Vecamyl	Mecamylamine Hydrochloride	Vyera Pharmaceuticals, LLC	ANDA	Current
79739-7183	Mecamylamine Hydrochloride	Mecamylamine Hydrochloride	LGM Pharma Solutions, LLC	ANDA	Current