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 43.

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
2026-09-14 22:38:34	2026-08	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`84e616aacf4f…`
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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	Bryant Ranch Prepack	a5d54183-06a9-4ae1-93b9-e9a2e03ad42b	2025-06-13	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Loratadine	LORATADINE	Granules Pharmaceuticals Inc.	d15add22-bc2d-9730-e053-2a95a90acd3f	2025-05-05	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 70010-162
Loratadine	LORATADINE	Bi-Mart	1dd299e7-dfdd-459b-bb2b-83e37dd2e63d	2025-04-11	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
ValuMeds Allergy Relief	LORATADINE	Cabinet Health P.B.C.	7a67f879-9df9-4536-8fd5-4b9aed05fb47	2025-02-28	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Loratadine	LORATADINE	Advanced Rx LLC	e96b4671-82dc-4cc6-a8bf-ef6f1efd8a7d	2025-02-25	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
LORATADINE	LORATADINE	AMZ789 LLC	db71197e-d633-644d-e053-2a95a90a261d	2025-01-08	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 73629-003
Loratadine	LORATADINE	Spirit Pharmaceuticals LLC	af0cdab2-27a4-5f30-e053-2a95a90a5e71	2024-12-13	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 68210-4110
24 / 7 Life Non-Drowsy Allergy Relief	LORATADINE TABLET	Lil' Drug Store Products, Inc.	efd0703f-f069-566e-e053-2995a90a74e4	2024-07-22	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 29485-5515 ndc (product): 29485-8156
Non-Drowsy Allergy Relief, 24-7 Life	LORATADINE TABLET	Lil' Drug Store Products, Inc.	031ecc85-8324-4505-e063-6294a90a580b	2024-04-10	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
XL - 3 Allergy	XL - 3 ALLERGY	Selder, S.A. de C.V.	059a6e72-888e-4cb3-8722-4c3acbd6b4b0	2024-04-10	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
LORATADINE ALLERGY RELIEF 10mg	LORATADINE	YYBA CORP	dcb63e1b-d499-2e84-e053-2995a90af5c7	2024-01-03	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 73581-230
Allergy Relief	LORATADINE	AMERIFOODS TRADING COMPANY	f6ce5292-f698-dd2f-e053-6394a90ad74a	2023-11-02	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Allergy Relief	LORATADINE	FSA STORE INC.	ec6b31f3-ee68-1fbc-e053-2a95a90a05aa	2023-01-12	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 81522-393
LORATADINE	LORATADINE	Camber Consumer Care Inc	1e92f77f-d4ba-4f34-96f9-daf878b4ea6a	2022-12-06	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 69230-328
Allergy Relief	LORATADINE	AAA PHARMACEUTICAL, INC.	9c8535e3-6a60-4640-b37e-a2260936d9af	2022-04-21	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 57344-193
Allergy Relief	LORATADINE	DISCOUNT DRUG MART	c29bf35f-1f19-c3c9-e053-2995a90ac1b6	2021-07-12	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 53943-193
Allergy Relief	LORATADINE	HARRIS TEETER	b8f67f52-906e-c7a8-e053-2995a90a5cbd	2021-04-29	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 72036-193
Allergy Relief	LORATADINE 10MG	First Aid Direct	3a580dc7-ff09-462c-9b18-205105349035	2020-11-12	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 53117-414
Allergy Relief	LORATADINE	Marc Glassman, Inc.	717ccb47-e13c-4464-b6e6-bea8f24d4663	2020-09-28	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 68998-414
Allergy Relief	LORATADINE	Allegiant Health	f0db3a13-43e6-4243-9a3a-7808ddd005e1	2020-06-16	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722 ndc (product): 69168-414

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 · 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