Application 076134

Type: ANDA
Sponsor: SUN PHARM INDS 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
A076134-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2003-08-18

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	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	Cardinal Health 107, LLC	64489b01-a4a7-4c6d-ac84-1dfbd1388d84	2026-06-04	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
MEDIQUE Loradamed	LORATADINE	Sportpharm LLC	d6bf0e68-f87c-49ee-a15d-df7f5bfa6221	2026-04-24	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	PD-Rx Pharmaceuticals, Inc.	7127b39d-3686-4249-b720-43c02b4c4654	2026-03-19	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 55289-728
Loratadine Allergy Relief	LORATADINE	A-S Medication Solutions	a53e5635-8633-4c28-b04f-cdfb3d851e68	2026-02-19	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 50090-2387
Green Guard 24 Hour Allergy Relief	LORATADINE	Unifirst First Aid Corporation	32092beb-c177-4b6b-afa4-b4b5d64621f4	2025-11-21	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 47682-913 ndc (product): 47682-203
Loratadine Allergy Relief	LORATADINE	Marlex Pharmaceuticals, Inc.	ec08a6ee-3d71-0fa9-e053-2995a90a9cb1	2025-11-18	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 10135-763
McKesson Loratadine	LORATADINE 10 MG	McKesson Medical Surgical	c6a3056e-792e-52a4-e053-2a95a90a8361	2025-10-23	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	Asclemed USA, Inc.	332bda00-1350-2d33-e063-6394a90a8bd7	2025-05-21	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	A-S Medication Solutions	0be70365-57ee-4f2e-a30f-bdd5c292992d	2025-02-20	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	A-S Medication Solutions	baaf9c23-0b54-46a2-8aec-13264479a6d7	2025-02-20	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine	LORATADINE	American Health Packaging	411f3692-99ff-49d7-8594-e6f404f5861f	2024-11-21	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	Proficient Rx LP	a6b9a1bf-1013-4a15-b3b2-a226a75a1ffb	2024-10-01	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 63187-100
Loratadine Allergy Relief	LORATADINE	Bryant Ranch Prepack	40914eeb-3a85-4691-9fb8-2df72ba1f709	2024-04-05	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	Bryant Ranch Prepack	94642b79-f91a-429f-87f4-dad326d4f3ed	2024-04-03	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 63629-7772
Loratadine Allergy Relief	LORATADINE	OHM LABORATORIES INC.	c35f2cc1-f76d-4824-b0a5-747bca0c3b85	2023-12-08	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 51660-526
Handy Solutions 24 Hour Allergy	LORATADINE	Navajo Manufacturing Company Inc.	67263031-9095-48f2-8b34-e589b28a7416	2023-03-15	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 67751-163
Loratadine	LORATADINE	SAFEWAY INC.	1092b8af-25f2-4c25-b3bc-5ffb14e96024	2021-12-21	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 21130-526
Loratadine	LORATADINE	CVS Pharmacy	e63f082c-ff50-43ed-ad2c-598b352413e8	2021-12-21	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 59779-528
Loratadine Allergy Relief	LORATADINE	DISCOUNT DRUG MART	55d3ee36-116b-4ec6-b409-79d67a2b54ae	2018-09-14	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 53943-975
Loratadine Allergy Relief	LORATADINE	WinCo Foods, LLC	506a60e8-7fec-4bb0-babc-204058ae120f	2018-08-29	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 67091-245 ndc (product): 67091-246

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 115 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0179-8317	Loratadine	Loratadine	Kaiser Foundation Hospitals	ANDA	Current
0363-0522	Loratadine	Loratadine	Walgreen Company	ANDA	Current
0904-6074	Loratadine	Loratadine	Major Pharmaceuticals	ANDA	Current
0904-6074	Loratadine	Loratadine	Major Pharmaceuticals	ANDA	Current
0904-6074	Loratadine	Loratadine	Major Pharmaceuticals	ANDA	Current
0904-6074	Loratadine	Loratadine	Major Pharmaceuticals	ANDA	Current
10135-763	Loratadine Allergy Relief	Loratadine	Marlex Pharmaceuticals, Inc.	ANDA	Current
15127-715	Loratadine	Loratadine	Select Brand	ANDA	Current
21130-526	Loratadine	Loratadine	SAFEWAY INC.	ANDA	Current
21130-526	Loratadine	Loratadine	SAFEWAY INC.	ANDA	Current
37012-526	Loratadine	Loratadine	Shopko Stores Operating Co., LLC	ANDA	Current
37205-346	LEADER Loratadine	loratadine	Cardinal Health	ANDA	Current
37808-529	Loratadine Allergy Relief	Loratadine	HEB	ANDA	Current
41163-526	Loratadine	Loratadine	SUPERVALU INC.	ANDA	Current
46122-158	Loratadine	Loratadine	Amerisource Bergen	ANDA	Current
47682-203	MEDIQUE Loradamed	Loratadine	Unifirst First Aid Corporation	ANDA	Current
47682-203	MEDIQUE Loradamed	Loratadine	Unifirst First Aid Corporation	ANDA	Current
47682-203	MEDIQUE Loradamed	Loratadine	Unifirst First Aid Corporation	ANDA	Current
47682-203	MEDIQUE Loradamed	Loratadine	Unifirst First Aid Corporation	ANDA	Current
47682-203	MEDIQUE Loradamed	Loratadine	Unifirst First Aid Corporation	ANDA	Current
47682-203	MEDIQUE Loradamed	Loratadine	Unifirst First Aid Corporation	ANDA	Current
47682-913	Medi First Plus Allergy Relief	Loratadine	Unifirst First Aid Corporation	ANDA	Current
47682-913	Medi First Plus Allergy Relief	Loratadine	Unifirst First Aid Corporation	ANDA	Current
47682-913	Medi First Plus Allergy Relief	Loratadine	Unifirst First Aid Corporation	ANDA	Current
47682-913	Medi First Plus Allergy Relief	Loratadine	Unifirst First Aid Corporation	ANDA	Current
47682-913	Medi First Plus Allergy Relief	Loratadine	Unifirst First Aid Corporation	ANDA	Current
49614-170	Medicine Shoppe Loratadine Allergy Relief	Loratadine	The Medicine Shoppe International	ANDA	Current
50090-2387	Loratadine Allergy Relief	Loratadine	A-S Medication Solutions	ANDA	Current
50090-2387	Loratadine Allergy Relief	Loratadine	A-S Medication Solutions	ANDA	Current
50090-2387	Loratadine Allergy Relief	Loratadine	A-S Medication Solutions	ANDA	Current
51655-027	Loratadine	Loratadine	Northwind Pharmaceuticals, LLC	ANDA	Current
51660-209	Loratadine	Loratadine	Ohm Laboratories Inc.	ANDA	Current
51660-526	Loratadine Allergy Relief	Loratadine	OHM LABORATORIES INC.	ANDA	Current
51660-526	Loratadine Allergy Relief	Loratadine	OHM LABORATORIES INC.	ANDA	Current
53002-7490	Loratadine Allergy Relief	Loratadine	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-7490	Loratadine Allergy Relief	Loratadine	RPK Pharmaceuticals, Inc.	ANDA	Current
53329-651	Loratadine	Loratadine	Medline Industries, Inc.	ANDA	Current
53943-975	Loratadine Allergy Relief	Loratadine	DISCOUNT DRUG MART	ANDA	Current
55289-728	Loratadine Allergy Relief	Loratadine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-728	Loratadine Allergy Relief	Loratadine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-728	Loratadine Allergy Relief	Loratadine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-728	Loratadine Allergy Relief	Loratadine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-728	Loratadine Allergy Relief	Loratadine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-728	Loratadine Allergy Relief	Loratadine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-728	Loratadine Allergy Relief	Loratadine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-728	Loratadine Allergy Relief	Loratadine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-728	Loratadine Allergy Relief	Loratadine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55315-528	Loratadine	Loratadine	Fred's Inc.	ANDA	Current
55315-528	Loratadine	Loratadine	Fred's Inc.	ANDA	Current
55319-526	Loratadine	Loratadine	Family Dollar Services, Inc.	ANDA	Current
55670-478	Moore Medical Loratadine	Loratadine	Moore Medical LLC	ANDA	Current
55670-478	Moore Medical Loratadine	Loratadine	Moore Medical LLC	ANDA	Current
55670-478	Moore Medical Loratadine	Loratadine	Moore Medical LLC	ANDA	Current
55670-478	Moore Medical Loratadine	Loratadine	Moore Medical LLC	ANDA	Current
55700-097	Loratadine Allergy Relief	Loratadine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-097	Loratadine Allergy Relief	Loratadine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-097	Loratadine Allergy Relief	Loratadine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-097	Loratadine Allergy Relief	Loratadine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-097	Loratadine Allergy Relief	Loratadine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
56062-526	Loratadine	Loratadine	Publix Super Markets Inc	ANDA	Current
56062-526	Loratadine	Loratadine	Publix Super Markets Inc	ANDA	Current
59564-251	Loratadine	Loratadine	Innovative Manufacturing and Distribution Services, Inc.	ANDA	Current
59779-528	Loratadine	Loratadine	CVS Pharmacy	ANDA	Current
59779-528	Loratadine	Loratadine	CVS Pharmacy	ANDA	Current
61715-017	Loratadine	Loratadine	Kinray	ANDA	Current
63187-100	Loratadine Allergy Relief	Loratadine	Proficient Rx LP	ANDA	Current
63187-100	Loratadine Allergy Relief	Loratadine	Proficient Rx LP	ANDA	Current
63187-100	Loratadine Allergy Relief	Loratadine	Proficient Rx LP	ANDA	Current
63629-7772	Loratadine Allergy Relief	Loratadine	Bryant Ranch Prepack	ANDA	Current
63629-7772	Loratadine Allergy Relief	Loratadine	Bryant Ranch Prepack	ANDA	Current
63629-7772	Loratadine Allergy Relief	Loratadine	Bryant Ranch Prepack	ANDA	Current
63868-151	Loratadine	Loratadine	Chain Drug Marketing Association Inc.	ANDA	Current
63941-526	Loratadine	Loratadine	Valu Merchandisers Company	ANDA	Current
64725-0526	Loratadine Allergy Relief	Loratadine	TYA Pharmaceuticals	ANDA	Current
67046-452	Loratadine Allergy Relief	Loratadine	Contract Pharmacy Services-PA	ANDA	Current
67091-245	Loratadine Allergy Relief	Loratadine	WinCo Foods, LLC	ANDA	Current
67091-246	Loratadine Allergy Relief	Loratadine	WinCo Foods, LLC	ANDA	Current
67751-163	Handy Solutions 24 Hour Allergy	LORATADINE	Navajo Manufacturing Company Inc.	ANDA	Current
67751-163	Handy Solutions 24 Hour Allergy	LORATADINE	Navajo Manufacturing Company Inc.	ANDA	Current
68016-526	Loratadine	Loratadine	Premier Value	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43056	ORIG	2012-03-28
31084	ORIG	2003-04-16