Application 210722

Type: ANDA
Sponsor: GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORATADINE	LORATADINE	TABLET;ORAL	10MG	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
A210722-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2019-12-23

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.

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	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`a50c72e98297…`

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 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	LORATADINE	Dr. Reddy's Laboratories Inc.	44da36d2-1881-e779-d3a2-13ea828f9240	2026-07-15	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Loratadine	LORATADINE	St. Mary's Medical Park Pharmacy	2bc586e4-5297-44cf-e063-6294a90a531d	2026-06-29	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Loratadine	LORATADINE	Preferred Pharmaceuticals Inc.	c6144a33-6b33-4aca-86e5-a3f688b8b317	2026-05-28	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Allergy Relief	LORATADINE	Grocery Outlet, Inc	441cfa86-a812-f67f-e063-6394a90a2118	2026-05-21	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Loratadine	LORATADINE	NuCare Pharmaceuticals,Inc.	16f00a3a-0777-f70c-e063-6294a90a71c9	2026-04-06	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
ALLERGY RELIEF 10 mg	LORATADINE	TWIN MED LLC	d943f548-aa0d-4476-e053-2a95a90a7bd4	2026-04-01	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 55681-303
Dr Simi All Day Allergy Relief	LORATADINE	Farmacias De Similares TX LLC	3c5b2eaa-24da-3314-e063-6294a90a5b21	2026-02-26	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Loratadine	LORATADINE	GRANULES USA, INC.	c3c9bc45-7ed5-abf4-e053-2995a90a40ff	2025-12-22	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 69848-019
Loratadine	LORATADINE	Safeway, Inc	f2a2a754-0170-e37c-e053-2a95a90a4dca	2025-12-19	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Loratadine 10mg	LORATADINE 10MG	Meijer	181b7dd1-ddc4-e799-e063-6294a90a9faa	2025-12-19	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Loratadine	LORATADINE	Walgreens	fd796139-ea9f-f4db-e053-6394a90acdf3	2025-12-19	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Allergy Relief	LORATADINE	Valu Merchandisers Company	05927511-6b7a-4e29-96b4-3043493acf11	2025-12-11	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 63941-193
CAREALL Allergy Relief	LORATADINE	New World Imports	4d15d926-9564-4bef-b8a9-768af7a0ab6a	2025-12-01	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Green Guard 24 Hour Allergy Relief	LORATADINE	Unifirst First Aid Corporation	f98a45fd-cda8-4884-e053-6294a90a57b5	2025-11-21	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Allergy Relief	LORATADINE	WinCo Foods, LLC	3dea627d-4b0c-e077-e063-6394a90a15a0	2025-11-03	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
McKesson Loratadine	LORATADINE 10 MG	McKesson Medical Surgical	c6a3056e-792e-52a4-e053-2a95a90a8361	2025-10-23	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
First Aid Direct Allergy Relief	LORATADINE TABLETS	Cintas Corporation	6b43e5a5-30a8-46ca-a44d-1e1abf567b51	2025-09-23	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 42961-120
Loratadine	LORATADINE	Granules India Limited	9bae1ba3-c0da-23a2-e053-2a95a90a58ed	2025-08-01	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 62207-787
Curist Allergy Relief	LORATADINE 10 MG	Little Pharma, Inc.	0c53cf0f-7682-a422-e063-6394a90ab764	2025-06-15	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Loratadine	LORATADINE	Bryant Ranch Prepack	0d74af21-3ef7-418b-a2ef-78737b0af288	2025-06-13	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29485-5515	24 / 7 Life Non-Drowsy Allergy Relief	loratadine tablet	Mechanical Servants, LLC	ANDA	Current
29485-8156	24 / 7 Life Non-Drowsy Allergy Relief	loratadine tablet	Mechanical Servants, LLC	ANDA	Current
42961-120	First Aid Direct Allergy Relief	Loratadine Tablets	Cintas Corporation	ANDA	Current
51824-075	CAREALL Loratadine	Loratadine	New World Imports	ANDA	Current
51824-075	CAREALL Loratadine	Loratadine	New World Imports	ANDA	Current
53117-414	Allergy Relief	Loratadine 10mg	First Aid Direct	ANDA	Current
53117-414	Allergy Relief	Loratadine 10mg	First Aid Direct	ANDA	Current
53943-193	Allergy Relief	Loratadine	DISCOUNT DRUG MART	ANDA	Current
55681-303	ALLERGY RELIEF	LORATADINE	TWIN MED LLC	ANDA	Current
55681-303	ALLERGY RELIEF	LORATADINE	TWIN MED LLC	ANDA	Current
57344-193	Allergy Relief	Loratadine	AAA PHARMACEUTICAL, INC.	ANDA	Current
57344-193	Allergy Relief	Loratadine	AAA PHARMACEUTICAL, INC.	ANDA	Current
62207-787	Loratadine	Loratadine	Granules India Ltd	ANDA	Current
62207-787	Loratadine	Loratadine	Granules India Limited	ANDA	Current
62207-787	Loratadine	Loratadine	Granules India Limited	ANDA	Current
63941-193	Allergy Relief	Loratadine	Valu Merchandisers Company	ANDA	Current
68210-4110	Loratadine	Loratadine	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4110	Loratadine	Loratadine	Spirit Pharmaceuticals LLC	ANDA	Current
68998-414	Allergy Relief	Loratadine	Marc Glassman, Inc.	ANDA	Current
68998-414	Allergy Relief	Loratadine	Marc Glassman, Inc.	ANDA	Current
68998-414	Allergy Relief	Loratadine	Marc Glassman, Inc.	ANDA	Current
68998-414	Allergy Relief	Loratadine	Marc Glassman, Inc.	ANDA	Current
69168-414	Allergy Relief	Loratadine	Allegiant Health	ANDA	Current
69168-414	Allergy Relief	Loratadine	Allegiant Health	ANDA	Current
69168-414	Allergy Relief	Loratadine	Allegiant Health	ANDA	Current
69230-328	LORATADINE	LORATADINE	Camber Consumer Care Inc	ANDA	Current
69848-019	Loratadine	Loratadine	GRANULES USA, INC.	ANDA	Current
70010-162	Loratadine	Loratadine	Granules Pharmaceuticals Inc.	ANDA	Current
70010-162	Loratadine	Loratadine	Granules Pharmaceuticals Inc.	ANDA	Current
70010-162	Loratadine	Loratadine	Granules Pharmaceuticals Inc.	ANDA	Current
71309-007	Loratadine	Loratadine	Safrel Pharmaceuticals, LLC	ANDA	Current
72036-193	Allergy Relief	Loratadine	HARRIS TEETER	ANDA	Current
72036-193	Allergy Relief	Loratadine	HARRIS TEETER	ANDA	Current
73581-230	LORATADINE ALLERGY RELIEF	LORATADINE	YYBA CORP	ANDA	Current
73629-003	LORATADINE	LORATADINE	AMZ789 LLC	ANDA	Current
81522-393	Allergy Relief	Loratadine	FSA STORE INC.	ANDA	Current