Application 209116

Type: ANDA
Sponsor: AUROBINDO PHARMA 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 1.

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
A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2017-10-30

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209116-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-10-30	`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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Aurohealth LLC	4726af84-83c1-456d-995c-f6a8d1583f8b	2026-05-27	Warnings	Exact identifier application applno (ANDA): 209116 application number: ANDA209116 ndc (product): 58602-807
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	WALGREEN CO.	1fcb601c-19d2-4db9-938b-b4f98ba9332f	2024-06-26	Warnings	Exact identifier application applno (ANDA): 209116 application number: ANDA209116 ndc (product): 0363-0094
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy, Inc.	e9161bb2-190f-14b3-e053-2995a90a9b2f	2024-06-01	Warnings	Exact identifier application applno (ANDA): 209116 application number: ANDA209116 ndc (product): 51316-007
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	KROGER COMPANY	b8b2c45d-3aba-d98a-e053-2a95a90a879b	2024-05-18	Warnings	Exact identifier application applno (ANDA): 209116 application number: ANDA209116 ndc (product): 30142-059
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Cardinal Health	c3b40d04-7eef-4c80-a604-808d2be72ad7	2024-05-06	Warnings	Exact identifier application applno (ANDA): 209116 application number: ANDA209116
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Rugby Laboratories	cc6df813-9175-4c0b-a8e4-afcaa3aa833f	2024-05-06	Warnings	Exact identifier application applno (ANDA): 209116 application number: ANDA209116

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0094	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-0094	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-0094	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-0094	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-0094	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	WALGREEN CO.	ANDA	Current
30142-059	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	KROGER COMPANY	ANDA	Current
30142-059	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	KROGER COMPANY	ANDA	Current
51316-007	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	CVS Pharmacy, Inc.	ANDA	Current
58602-807	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-807	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-807	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-807	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Aurohealth LLC	ANDA	Current
62011-0376	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	McKESSON Corporation	ANDA	Current