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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`84e616aacf4f…`
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…`

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 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	Valu Merchandisers Company	0cd920b4-b15a-4ca9-87e2-4dd523c6d1f8	2018-08-28	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine	LORATADINE	Chain Drug Marketing Association Inc.	b4edf5b1-398d-405a-8a42-76044b31ebb7	2018-08-27	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	HEB	6703e4f3-e9b8-4c70-9085-3d6ac0d7fbda	2018-05-14	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine	LORATADINE	Premier Value	778a6979-ea47-4381-8c40-84b3c2325a7e	2018-01-11	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	LIDL US, LLC	11bc027c-d28d-45f0-a4cb-24a3834a6995	2018-01-09	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (product): 71141-132

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 2 of 2 · 115 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68071-3208	Loratadine Allergy Relief	Loratadine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3208	Loratadine Allergy Relief	Loratadine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3208	Loratadine Allergy Relief	Loratadine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4788	Loratadine Allergy Relief	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4788	Loratadine Allergy Relief	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4910	Loratadine Allergy Relief	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4910	Loratadine Allergy Relief	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5049	Loratadine Allergy Relief	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5049	Loratadine Allergy Relief	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-248	Loratadine	Loratadine	American Health Packaging	ANDA	Current
68084-248	Loratadine	Loratadine	American Health Packaging	ANDA	Current
68084-248	Loratadine	Loratadine	American Health Packaging	ANDA	Current
68599-4784	McKesson Loratadine	Loratadine 10 mg	McKesson Medical Surgical	ANDA	Current
68599-4784	McKesson Loratadine	Loratadine 10 mg	McKesson Medical Surgical	ANDA	Current
68788-7482	Loratadine Allergy Relief	Loratadine	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1399	Loratadine Allergy Relief	Loratadine	REMEDYREPACK INC.	ANDA	Current
70518-1399	Loratadine Allergy Relief	Loratadine	REMEDYREPACK INC.	ANDA	Current
70518-1399	Loratadine Allergy Relief	Loratadine	REMEDYREPACK INC.	ANDA	Current
70518-1399	Loratadine Allergy Relief	Loratadine	REMEDYREPACK INC.	ANDA	Current
70518-1399	Loratadine Allergy Relief	Loratadine	REMEDYREPACK INC.	ANDA	Current
70518-1399	Loratadine Allergy Relief	Loratadine	REMEDYREPACK INC.	ANDA	Current
70518-1399	Loratadine Allergy Relief	Loratadine	REMEDYREPACK INC.	ANDA	Current
70518-1399	Loratadine Allergy Relief	Loratadine	REMEDYREPACK INC.	ANDA	Current
70934-205	Loratadine Allergy Relief	Loratadine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-205	Loratadine Allergy Relief	Loratadine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-779	Loratadine Allergy Relief	Loratadine	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71141-132	Loratadine Allergy Relief	Loratadine	LIDL US, LLC	ANDA	Current
71335-0100	Loratadine Allergy Relief	Loratadine	Bryant Ranch Prepack	ANDA	Current
71335-0100	Loratadine Allergy Relief	Loratadine	Bryant Ranch Prepack	ANDA	Current
71335-0100	Loratadine Allergy Relief	Loratadine	Bryant Ranch Prepack	ANDA	Current
72559-005	Curist Allergy Relief	Loratadine	Little Pharma, Inc.	ANDA	Current
72559-006	Curist Allergy Relief	Loratadine	Little Pharma, Inc.	ANDA	Current
73408-913	Crane Safety Allergy Relief	loratadine	Crane Safety LLC	ANDA	Current
73408-913	Crane Safety Allergy Relief	loratadine	Crane Safety LLC	ANDA	Current
82652-021	Diphen	Benzocaine, Benzalkonium chloride, Lidocaine hydrochloride, Hydrocortisone, Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, Calcium Carbonate, Ibuprofen, Loratadine, Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride, Potassium Chloride, Magnesium Oxide, Meclizine Hydrochloride, and Bismuth Subsalicylate	Remedy Pack LLC	ANDA	Current

Documents#

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