Application 040829

Type: ANDA
Sponsor: AVANTHI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORPHENIRAMINE MALEATE	CHLORPHENIRAMINE MALEATE	TABLET, EXTENDED RELEASE;ORAL	12MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040829-001	CHLORPHENIRAMINE MALEATE	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL		RS	2009-05-13

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`e64feba35796…`

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
Chlorphen-12	CHLORPHENIRAMINE MALEATE	KVK-Tech, Inc.	84409269-fe9b-469e-9a66-27b1475231a3	2018-12-19	Warnings	Exact identifier application applno (ANDA): 040829 application number: ANDA040829 ndc (product): 10702-017
Allergy Relief	CHLORPHENIRAMINE MALEATE	CVS Pharmacy	626aa162-f5e3-45c0-b5ac-d70bff255aed	2017-01-19	Warnings	Exact identifier application applno (ANDA): 040829 application number: ANDA040829 ndc (product): 69842-017

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-017	Chlorphen-12	Chlorpheniramine Maleate	KVK-Tech, Inc.	ANDA	Current
37205-117	Chlorpheniramine Maleate	Chlorpheniramine Maleate	Cardinal Health, Inc.	ANDA	Current
58809-363	Chlorphen SR	Chlorpheniramine Maleate	GM Pharmaceuticals, INC	ANDA	Current
69842-017	Allergy Relief	Chlorpheniramine Maleate	CVS Pharmacy	ANDA	Current