Application 207484

Type: ANDA
Sponsor: MIKART

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBINOXAMINE MALEATE	CARBINOXAMINE MALEATE	TABLET;ORAL	6MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A207484-001	CARBINOXAMINE MALEATE	CARBINOXAMINE MALEATE	6MG	TABLET / ORAL	AB	RS	2016-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A207484-001	AB

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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A207484-001	CARBINOXAMINE MALEATE	6MG	TABLET / ORAL		RS	2016-05-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207484-001	CARBINOXAMINE MALEATE	6MG	TABLET / ORAL		RS	2016-05-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207484-001	CARBINOXAMINE MALEATE	6MG	TABLET / ORAL		RS	2016-05-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207484-001	CARBINOXAMINE MALEATE	6MG	TABLET / ORAL	AB	RS	2016-05-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207484-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207484-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207484-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207484-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207484-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207484-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207484-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207484-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207484-001	AA	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207484-001	AB	1	`a50c72e98297…`

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
Carbinoxamine Maleate	CARBINOXAMINE MALEATE	BluCrest Pharmaceuticals, LLC	163db29b-f035-6696-e063-6294a90a7e06	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207484 application number: ANDA207484
RyVent	CARBINOXAMINE MALEATE	Carwin Pharmaceutical Associates, LLC	13ed76c7-49bd-4527-83dc-b4c7d0da9fff	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207484 application number: ANDA207484 ndc (product): 15370-130

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
15370-130	RyVent	carbinoxamine maleate	Carwin Pharmaceutical Associates, LLC	ANDA	Current
15370-130	RyVent	carbinoxamine maleate	Carwin Pharmaceutical Associates, LLC	ANDA	Current
15370-130	RyVent	carbinoxamine maleate	Carwin Pharmaceutical Associates, LLC	ANDA	Current
46672-857	carbinoxamine maleate	carbinoxamine maleate	Mikart, LLC	ANDA	Current
46672-857	carbinoxamine maleate	carbinoxamine maleate	Mikart, Inc.	ANDA	Current
69067-240	Carbinoxamine Maleate	CARBINOXAMINE MALEATE	Foxland Pharmaceuticals, Inc.	ANDA	Current
69067-240	Carbinoxamine Maleate	CARBINOXAMINE MALEATE	Foxland Pharmaceuticals, Inc.	ANDA	Current
69067-240	Carbinoxamine Maleate	CARBINOXAMINE MALEATE	Foxland Pharmaceuticals, Inc.	ANDA	Current