Application 076557

Type: ANDA
Sponsor: SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	10MG;240MG	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
A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL			2004-09-22

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 · 43 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	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`f41ea6bd6efb…`

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 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Publix Super Markets Inc	63b73a3e-4f3a-40f1-98c0-13a2bca4f4e0	2018-10-22	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557 ndc (product): 56062-724
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	HEB	0504f63e-e89c-49ad-9094-65fac328482e	2018-05-24	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557 ndc (product): 37808-427
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	HEB	74e7670a-5eca-4556-a860-0d36e8561518	2018-04-12	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557 ndc (product): 37808-724

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 · 70 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0725	Loratadine and Pseudoephedrine	Loratadine and Pseudoephedrine	Walgreen Company	ANDA	Current
0363-0725	Loratadine and Pseudoephedrine	Loratadine and Pseudoephedrine	Walgreen Company	ANDA	Current
0904-5833	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Major Pharmaceuticals	ANDA	Current
0904-5833	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Major Pharmaceuticals	ANDA	Current
11673-165	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Target Corporation	ANDA	Current
11822-9990	Loratadine and Pseudoephedrine	LORATADINE and PSEUDOEPHEDRINE SULFATE	Rite Aid	ANDA	Current
11822-9990	Loratadine and Pseudoephedrine	LORATADINE and PSEUDOEPHEDRINE SULFATE	Rite Aid	ANDA	Current
11822-9990	Loratadine and Pseudoephedrine	LORATADINE and PSEUDOEPHEDRINE SULFATE	Rite Aid	ANDA	Current
11822-9990	Loratadine and Pseudoephedrine	LORATADINE and PSEUDOEPHEDRINE SULFATE	Rite Aid	ANDA	Current
15127-717	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Select Brand	ANDA	Current
21130-724	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Safeway Inc.	ANDA	Current
21130-724	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Safeway Inc.	ANDA	Current
21695-729	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	Rebel Distributors Corp	ANDA	Current
30142-724	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	The Kroger Company	ANDA	Current
30142-724	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	The Kroger Company	ANDA	Current
36800-724	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Topco Associates LLC	ANDA	Current
37012-724	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Shopko Stores Operating Co., LLC	ANDA	Current
37205-348	Leader Allergy Relief D-24	Loratadine and Pseudoephedrine Sulfate	Cardinal Health	ANDA	Current
37808-427	Loratadine and Pseudoephedrine Sulfate	loratadine and pseudoephedrine sulfate	HEB	ANDA	Current
37808-724	Loratadine and Pseudoephedrine Sulfate	loratadine and pseudoephedrine sulfate	HEB	ANDA	Current
41163-165	Loratadine and Pseudoephedrine	Loratadine and Pseudoephedrine	SUPERVALU INC.	ANDA	Current
41250-724	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Meijer Distribution, Inc.	ANDA	Current
41250-724	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Meijer Distribution, Inc.	ANDA	Current
46122-167	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Amerisource Bergen	ANDA	Current
46122-167	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Amerisource Bergen	ANDA	Current
46122-167	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Amerisource Bergen	ANDA	Current
46122-383	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	AMERISOURCE BERGEN	ANDA	Current
46122-383	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	AMERISOURCE BERGEN	ANDA	Current
49035-488	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	WAL-MART STORES, INC	ANDA	Current
49348-543	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	STRATEGIC SOURCING SERVICES	ANDA	Current
49348-543	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Sunmark	ANDA	Current
49614-172	Medicine Shoppe Allergy Relief D24	Loratadine and Pseudoephedrine Sulfate	The Medicine Shoppe International	ANDA	Current
51660-488	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	Ohm Laboratories Inc.	ANDA	Current
51660-491	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	Ohm Laboratories Inc.	ANDA	Current
51660-491	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	Ohm Laboratories Inc.	ANDA	Current
51660-724	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	Ohm Laboratories Inc.	ANDA	Current
51660-724	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	Ohm Laboratories Inc.	ANDA	Current
51660-724	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	Ohm Laboratories Inc.	ANDA	Current
56062-724	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Publix Super Markets Inc	ANDA	Current
59779-726	ALLERGY RELIEF-D	Loratadine and Pseudoephedrine	CVS Pharmacy	ANDA	Current
59779-726	ALLERGY RELIEF-D	Loratadine and Pseudoephedrine	CVS Pharmacy	ANDA	Current
61715-016	Loratadine and Pseudoephedrine	Loratadine and Pseudoephedrine	Kinray	ANDA	Current
62011-0071	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Health Mart	ANDA	Current
62011-0071	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Health Mart	ANDA	Current
62011-0071	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Strategic Sourcing Services LLC	ANDA	Current
62011-0071	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Strategic Sourcing Services LLC	ANDA	Current
63187-305	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	Proficient Rx LP	ANDA	Current
63187-305	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	Proficient Rx LP	ANDA	Current
63629-7766	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	Bryant Ranch Prepack	ANDA	Current
63629-7766	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	Bryant Ranch Prepack	ANDA	Current
63629-7766	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	Bryant Ranch Prepack	ANDA	Current
63868-154	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Chain Drug Marketing Association Inc.	ANDA	Current
63981-724	KIRKLAND SIGNATURE ALLERCLEAR D 12 HR	loratadine and pseudoephedrine sulfate	Kirkland-COSTCO WHOLESALE COMPANY	ANDA	Current
63981-724	KIRKLAND SIGNATURE ALLERCLEAR D 24 HR	loratadine and pseudoephedrine sulfate	Kirkland-COSTCO WHOLESALE COMPANY	ANDA	Current
68016-724	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Chain Drug Consortium, LLC	ANDA	Current
68016-724	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	Chain Drug Consortium, LLC	ANDA	Current
70000-0162	Leader Allergy Relief D-24	Loratadine and Pseudoephedrine Sulfate	Cardinal Health	ANDA	Current
70000-0162	Leader Allergy Relief D-24	Loratadine and Pseudoephedrine Sulfate	Cardinal Health	ANDA	Current
70000-0162	Leader Allergy Relief D-24	Loratadine and Pseudoephedrine Sulfate	Cardinal Health	ANDA	Current
70000-0162	Leader Allergy Relief D-24	Loratadine and Pseudoephedrine Sulfate	Cardinal Health	ANDA	Current
70518-0371	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-0371	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-0371	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-0371	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-0371	Loratadine and Pseudoephedrine Sulfate	Loratadine and Pseudoephedrine Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-0653	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	REMEDYREPACK INC.	ANDA	Current
70518-0653	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	REMEDYREPACK INC.	ANDA	Current
70518-0653	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	REMEDYREPACK INC.	ANDA	Current
70518-0653	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	REMEDYREPACK INC.	ANDA	Current
70518-0653	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22570	ORIG	2011-02-15