Application 211075

Type: ANDA
Sponsor: GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
002	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL			2019-10-18
A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL			2019-10-18

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`74a2ff9319b5…`

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 3 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6dc0893-b81b-4f96-e053-6294a90a856f	2023-11-02	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	c4f9224c-4c3d-74bd-e053-2995a90a1452	2023-10-30	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 36800-653
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	fabb8c0d-b4da-ab73-e053-6394a90ab8b5	2023-05-22	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
allergy relief	FEXOFENADINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	ccff9b0f-8ae5-057f-e053-2a95a90ac2b1	2023-05-17	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 41163-292
Crcle Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Innovus Pharmaceuticals, Inc.	f7784610-7ca5-4489-b391-f2b3f3f6549b	2023-04-08	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Safrel Pharmaceuticals, LLC.	d6120f56-ab28-2696-e053-2995a90adf47	2023-03-28	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 71309-091
Allergy Relief	FEXOFENADINE HCL	CVS PHARMACY, INC	57be0a69-9c5e-41a1-abd3-0b0e8a81093a	2023-02-16	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HARRIS TEETER	e5429440-fc89-4200-e053-2995a90afc7d	2022-11-23	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 72036-191
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	MARC GLASSMAN, INC.	c4f93336-cfd8-e023-e053-2995a90a9df0	2022-10-06	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 68998-292
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HEB	7cb25829-3aee-4a82-869d-ab4259626584	2022-05-31	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 37808-391
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HEB	d8b852a1-7315-4047-aed6-cd40c7a39e70	2022-05-31	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 37808-392
Allergy Relief	FEXOFENADINE HCL	Best Choice (Valu Merchandisers Company)	c3c56f76-636c-45fa-8c1a-63da7b491bc5	2022-05-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 63941-801
Allergy Relief Non Drowsy	FEXOFENADINE HCL	Allegiant Health	219606a8-9a3e-4c30-adb1-984f3f4e72c7	2022-05-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 69168-437
Allergy Relief Non Drowsy	FEXOFENADINE HCL	WinCo Foods	4b1fa4dd-885e-4873-a98f-3656dad0594c	2022-01-06	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 67091-386
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	DISCOUNT DRUG MART	c5106c63-af53-c169-e053-2a95a90afef2	2021-11-30	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 53943-392
ALLERGY RELIEF	FEXOFENADINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	c1be67ea-9973-49e2-e053-2995a90a423c	2021-10-24	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 72476-192
12HR Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CARDINAL HEALTH	ea5d0e55-2191-4094-b082-24b317f95752	2021-09-24	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 70000-0586
Allergy Relief	FEXOFENADINE HCL	Allegiant Health	25e72bd3-25c6-4943-92bb-27f9543e2d8a	2021-03-23	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 69168-413

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 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-8010	Allergy Relief	Fexofenadine HCl	Walgreens	ANDA	Current
0363-8010	Allergy Relief	Fexofenadine HCl	Walgreens	ANDA	Current
0363-8010	Allergy Relief	Fexofenadine HCl	Walgreens	ANDA	Current
21130-821	Allergy Relief	Fexofenadine HCl	Safeway, Inc.	ANDA	Current
21130-821	Allergy Relief	Fexofenadine HCl	Safeway, Inc.	ANDA	Current
36800-653	Allergy Relief	Fexofenadine Hydrochloride	TOPCO ASSOCIATES LLC	ANDA	Current
36800-653	Allergy Relief	Fexofenadine Hydrochloride	TOPCO ASSOCIATES LLC	ANDA	Current
36800-653	Allergy Relief	Fexofenadine Hydrochloride	TOPCO ASSOCIATES LLC	ANDA	Current
36800-761	Allergy Relief	Fexofenadine Hydrochloride	TOPCO ASSOCIATES LLC	ANDA	Current
37808-391	Allergy Relief	Fexofenadine Hydrochloride	HEB	ANDA	Current
37808-392	Allergy Relief	Fexofenadine Hydrochloride	HEB	ANDA	Current
41163-292	allergy relief	Fexofenadine Hydrochloride	UNFI	ANDA	Current
53943-392	Allergy Relief	Fexofenadine Hydrochloride	DISCOUNT DRUG MART	ANDA	Current
57344-292	Allergy Relief	Fexofenadine Hydrochloride	AAA PHARMACEUTICAL, INC.	ANDA	Current
57344-292	Allergy Relief	Fexofenadine Hydrochloride	AAA PHARMACEUTICAL, INC.	ANDA	Current
57344-292	Allergy Relief	Fexofenadine Hydrochloride	AAA PHARMACEUTICAL, INC.	ANDA	Current
62207-765	Fexofenadine Hydrochloride	Fexofenadine Hydrochloride	Granules India Ltd	ANDA	Current
62207-765	Fexofenadine Hydrochloride	Fexofenadine Hydrochloride	Granules India Ltd	ANDA	Current
62207-765	Fexofenadine Hydrochloride	Fexofenadine Hydrochloride	Granules India Ltd	ANDA	Current
62207-765	Fexofenadine Hydrochloride	Fexofenadine Hydrochloride	Granules India Ltd	ANDA	Current
62207-766	Fexofenadine Hydrochloride	Fexofenadine Hydrochloride	Granules India Ltd	ANDA	Current
62207-766	Fexofenadine Hydrochloride	Fexofenadine Hydrochloride	Granules India Ltd	ANDA	Current
62207-766	Fexofenadine Hydrochloride	Fexofenadine Hydrochloride	Granules India Ltd	ANDA	Current
62207-766	Fexofenadine Hydrochloride	Fexofenadine Hydrochloride	Granules India Ltd	ANDA	Current
63868-334	Allergy Relief	Fexofenadine Hydrochloride	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-334	Allergy Relief	Fexofenadine Hydrochloride	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63941-801	Allergy Relief	Fexofenadine HCl	Best Choice (Valu Merchandisers Company)	ANDA	Current
67091-386	Allergy Relief	Fexofenadine HCl	WinCo Foods	ANDA	Current
68016-887	Allergy Relief	Fexofenadine Hydrochloride	CHAIN DRUG CONSORTIUM	ANDA	Current
68016-887	Allergy Relief	Fexofenadine Hydrochloride	CHAIN DRUG CONSORTIUM	ANDA	Current
68998-292	Allergy Relief	Fexofenadine Hydrochloride	MARC GLASSMAN, INC.	ANDA	Current
68998-292	Allergy Relief	Fexofenadine Hydrochloride	MARC GLASSMAN, INC.	ANDA	Current
69168-413	Allergy Relief	Fexofenadine HCl	Allegiant Health	ANDA	Current
69168-413	Allergy Relief	Fexofenadine HCl	Allegiant Health	ANDA	Current
69168-437	Allergy Relief	Fexofenadine HCl	Allegiant Health	ANDA	Current
69168-437	Allergy Relief	Fexofenadine HCl	Allegiant Health	ANDA	Current
69168-437	Allergy Relief	Fexofenadine HCl	Allegiant Health	ANDA	Current
69842-492	Allergy Relief	Fexofenadine Hydrochloride	CVS PHARMACY	ANDA	Current
70000-0586	12HR Allergy Relief	Fexofenadine Hydrochloride	CARDINAL HEALTH	ANDA	Current
70692-134	Fexofenadine hydrochloride	Fexofenadine hydrochloride	Strive Pharmaceuticals Inc	ANDA	Current
70692-134	Fexofenadine hydrochloride	Fexofenadine hydrochloride	Strive Pharmaceuticals Inc	ANDA	Current
71288-407	Glycopyrrolate	Glycopyrrolate	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-408	Glycopyrrolate	Glycopyrrolate	Meitheal Pharmaceuticals Inc.	ANDA	Current
71309-091	Fexofenadine Hydrochloride	Fexofenadine Hydrochloride	Safrel Pharmaceuticals, LLC.	ANDA	Current
72036-191	Allergy Relief	Fexofenadine Hydrochloride	HARRIS TEETER	ANDA	Current
72036-292	Allergy Relief	Fexofenadine Hydrochloride	HARRIS TEETER	ANDA	Current
72036-292	Allergy Relief	Fexofenadine Hydrochloride	HARRIS TEETER	ANDA	Current
72476-192	ALLERGY RELIEF	Fexofenadine Hydrochloride	RETAIL BUSINESS SERVICES , LLC.	ANDA	Current
79903-090	Allergy Relief	Fexofenadine HCl	WALMART INC.	ANDA	Current
79903-090	Allergy Relief	Fexofenadine HCl	WALMART INC.	ANDA	Current
80539-801	Allergy Relief	Fexofenadine HCl	Allwell Health Inc	ANDA	Current
80539-801	Allergy Relief	Fexofenadine HCl	Allwell Health Inc	ANDA	Current
81522-613	Allergy Relief	Fexofenadine HCl	FSA Store Inc.	ANDA	Current
81522-613	Allergy Relief	Fexofenadine HCl	FSA Store Inc. (Caring Mills)	ANDA	Current