Application 076667

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	60MG;120MG	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
A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2014-11-18

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Dr. Reddy's Laboratories Limited	728632be-7e5c-2d06-4c95-bc8ecc9be2ec	2024-12-19	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667 ndc (product): 55111-447
Allergy and Congestion	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Rite Aid Corporation	90e1aa06-b769-e8ac-af88-1d6a256b9487	2020-05-19	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667 ndc (product): 11822-7388
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Dr. Reddy's Laboratories Inc.	6fd05737-d996-b5b6-dccf-bc179a9d606c	2019-09-09	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667 ndc (product): 43598-823
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	The Kroger Co.	8cf0b878-ec13-fd44-d56f-f44af7c249ed	2018-10-01	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667 ndc (product): 30142-611
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	The Kroger Co.	cb9e98a9-74e6-7a3e-9c5e-3bc35c4bbca6	2017-12-07	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667 ndc (product): 30142-447
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	HEB	0de7fc37-7f46-4e98-d5ac-d31a3c313a62	2017-12-07	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667 ndc (product): 37808-022
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	CVS Pharmacy	3e295047-1a46-a0d8-2e3f-ec4086f5aedb	2015-08-24	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667 ndc (product): 59779-508
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Walgreens Company	37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b3	2015-08-04	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667 ndc (product): 0363-1606

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0448	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	Walgreens Company	ANDA	Current
0363-1606	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	Walgreens Company	ANDA	Current
0536-1242	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	RUGBY LABORATORIES	ANDA	Current
11673-032	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	Target Brands Inc.	ANDA	Current
11822-7388	Allergy and Congestion	Fexofenadine HCl and Pseudoephedrine HCI	Rite Aid Corporation	ANDA	Current
30142-447	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	The Kroger Co.	ANDA	Current
30142-611	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	The Kroger Co.	ANDA	Current
30142-611	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	The Kroger Co.	ANDA	Current
37808-022	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	HEB	ANDA	Current
43598-823	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-823	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	Dr. Reddy's Laboratories Inc.	ANDA	Current
49035-273	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	Wal-mart Stores Inc.	ANDA	Current
49035-273	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	Wal-mart Stores Inc.	ANDA	Current
49035-273	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	Wal-mart Stores Inc.	ANDA	Current
55111-447	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-447	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	Dr. Reddy's Laboratories Limited	ANDA	Current
59779-508	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	CVS Pharmacy	ANDA	Current
62011-0455	Allergy and Congestion	Fexofenadine HCl and Pseudoephedrine HCI	Strategic Sourcing Services, LLC	ANDA	Current
62011-0455	Allergy and Congestion	Fexofenadine HCl and Pseudoephedrine HCI	Strategic Sourcing Services, LLC	ANDA	Current
62011-0455	Allergy and Congestion	Fexofenadine HCl and Pseudoephedrine HCI	Strategic Sourcing Services, LLC	ANDA	Current
69842-249	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	CVS Pharmacy	ANDA	Current
69842-249	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI	CVS Pharmacy	ANDA	Current
70000-0518	12HR Allergy and Congestion Relief	Fexofenadine HCl and Pseudoephedrine HCI	Cardinal Health	ANDA	Current
70000-0518	12HR Allergy and Congestion Relief	Fexofenadine HCl and Pseudoephedrine HCI	Cardinal Health	ANDA	Current
70000-0518	12HR Allergy and Congestion Relief	Fexofenadine HCl and Pseudoephedrine HCI	Cardinal Health	ANDA	Current