Application 202520

Type: ANDA
Sponsor: CAPELLON PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POLMON	DEXCHLORPHENIRAMINE MALEATE	SYRUP;ORAL	2MG/5ML	No	No

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
A202520-001	POLMON	DEXCHLORPHENIRAMINE MALEATE	2MG/5ML	SYRUP / ORAL		RS	2018-07-16

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL		RS	2018-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202520-001	POLMON	2MG/5ML	SYRUP / ORAL	AA		2018-07-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202520-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202520-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202520-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202520-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202520-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202520-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202520-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202520-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202520-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202520-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202520-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202520-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202520-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202520-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202520-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202520-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202520-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202520-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202520-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202520-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202520-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202520-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202520-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202520-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202520-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202520-001	AA	1	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Corphena	DEXCHLORPHENIRAMINE MALEATE	BluCrest Pharmaceuticals LLC	4694616b-4ef4-28a4-e063-6394a90ac5f6	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202520 application number: ANDA202520
RYCLORA	DEXCHLORPHENIRAMINE MALEATE	CARWIN PHARMACEUTICAL ASSOCIATES, LLC	aa4f80c9-e600-4bc0-8528-02a8162a36f0	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202520 application number: ANDA202520 ndc (product): 15370-150

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
15370-150	RYCLORA	Dexchlorpheniramine Maleate	CARWIN PHARMACEUTICAL ASSOCIATES, LLC	ANDA	Current
64543-600	POLMON	Dexchlorpheniramine Maleate	Capellon Pharmaceuticals, LLC	ANDA	Current
64543-600	POLMON	Dexchlorpheniramine Maleate	Capellon Pharmaceuticals, LLC	ANDA	Current
64543-600	POLMON	Dexchlorpheniramine Maleate	Capellon Pharmaceuticals, LLC	ANDA	Current
64543-600	POLMON	Dexchlorpheniramine Maleate	Capellon Pharmaceuticals, LLC	ANDA	Current
64543-600	POLMON	Dexchlorpheniramine Maleate	Capellon Pharmaceuticals, LLC	ANDA	Current
69067-102	Dexchlorpheniramine Maleate	Dexchlorpheniramine Maleate	Foxland Pharmaceuticals, Inc.	ANDA	Current
69067-102	Dexchlorpheniramine Maleate	Dexchlorpheniramine Maleate	Foxland Pharmaceuticals, Inc.	ANDA	Current