Application 208477

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORATADINE	LORATADINE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A208477-001	LORATADINE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2018-04-11

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`cb3db0bc1861…`

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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine ODT	LORATADINE	CVS Pharmacy, Inc.	37443f0d-bda0-4ddc-a2dd-f3daf495cb40	2025-03-17	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 69842-085
Loratadine ODT	LORATADINE	Wal-Mart Stores, Inc.	7679ee14-08aa-459c-9107-1a7144379962	2025-01-23	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 49035-806
Loratadine ODT	LORATADINE	WALGREEN CO.	7556b959-3ff2-4489-ae06-67ef398c623c	2024-06-18	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 0363-9937
CHILDRENS LORATADINE ODT	LORATADINE	WALGREEN CO.	cd597728-35fb-4e43-85ea-84af802e1983	2024-05-04	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 0363-4020
Loratadine ODT	LORATADINE	Better Living Brands, LLC	fad93257-bfcf-5e04-e053-6394a90a10a6	2023-09-25	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	Amerisource Bergen	d2524455-b6c4-442b-b139-666a555c5298	2023-07-10	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 46122-539
Loratadine ODT	LORATADINE	Chain Drug Consortium, LLC	7674009d-492d-4005-a652-f12b91428c0d	2022-11-04	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 68016-088
Loratadine ODT	LORATADINE	DISCOUNT DRUG MART	b4a11eb4-cff8-4280-9dc9-757d51100354	2022-11-04	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 53943-035
Loratadine ODT	LORATADINE	Ahold U.S.A., Inc,	092aec8d-57d5-4487-8e1a-b4b586bee7cf	2022-11-04	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 60000-950
Loratadine ODT	LORATADINE	Wal-Mart Stores, Inc.	f399f7ab-ab51-46ff-bce9-3014eb021930	2022-11-04	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 49035-806
Loratadine ODT	LORATADINE	Aurohealth LLC	1ba8e521-0b0f-419c-b7c3-fa9586f83f36	2022-11-03	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 58602-830
Loratadine ODT	LORATADINE	Aurohealth LLC	9f44382f-c289-402d-bb98-ec5fa80fc25d	2022-11-03	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 58602-821
Loratadine ODT	LORATADINE	Aurohealth LLC	8c119b12-f512-4207-b354-7244d1f9963a	2022-11-03	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 58602-744
Loratadine ODT	LORATADINE	Rugby Laboratories	f59f3400-da77-4eb7-be02-842071d87fae	2022-10-06	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 0536-1367
Loratadine ODT	LORATADINE	Aurohealth LLC	a6e04fe7-23d3-47d7-9f18-5c4298fbc28b	2022-06-20	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 58602-881

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-4020	CHILDRENS LORATADINE ODT	Loratadine	WALGREEN CO.	ANDA	Current
0363-4020	CHILDRENS LORATADINE ODT	Loratadine	WALGREEN CO.	ANDA	Current
0363-4020	CHILDRENS LORATADINE ODT	Loratadine	WALGREEN CO.	ANDA	Current
0363-9937	Loratadine ODT	Loratadine	WALGREEN CO.	ANDA	Current
0363-9937	Loratadine ODT	Loratadine	WALGREEN CO.	ANDA	Current
0363-9937	Loratadine ODT	Loratadine	WALGREEN CO.	ANDA	Current
0363-9937	Loratadine ODT	Loratadine	WALGREEN CO.	ANDA	Current
0536-1367	Loratadine ODT	Loratadine	Rugby Laboratories	ANDA	Current
46122-539	Loratadine ODT	Loratadine	Amerisource Bergen	ANDA	Current
46122-539	Loratadine ODT	Loratadine	Amerisource Bergen	ANDA	Current
46122-539	Loratadine ODT	Loratadine	Amerisource Bergen	ANDA	Current
46122-539	Loratadine ODT	Loratadine	Amerisource Bergen	ANDA	Current
46122-539	Loratadine ODT	Loratadine	Amerisource Bergen	ANDA	Current
49035-806	Loratadine ODT	Loratadine	Wal-Mart Stores, Inc.	ANDA	Current
49035-806	Loratadine ODT	Loratadine	Wal-Mart Stores, Inc.	ANDA	Current
49035-806	Loratadine ODT	Loratadine	Wal-Mart Stores, Inc.	ANDA	Current
49035-806	Loratadine ODT	Loratadine	Wal-Mart Stores, Inc.	ANDA	Current
49035-806	Loratadine ODT	Loratadine	Wal-Mart Stores, Inc.	ANDA	Current
49035-806	Loratadine ODT	Loratadine	Wal-Mart Stores, Inc.	ANDA	Current
53943-035	Loratadine ODT	Loratadine	DISCOUNT DRUG MART	ANDA	Current
53943-035	Loratadine ODT	Loratadine	DISCOUNT DRUG MART	ANDA	Current
53943-035	Loratadine ODT	Loratadine	DISCOUNT DRUG MART	ANDA	Current
58602-744	Loratadine ODT	Loratadine	Aurohealth LLC	ANDA	Current
58602-744	Loratadine ODT	Loratadine	Aurohealth LLC	ANDA	Current
58602-744	Loratadine ODT	Loratadine	Aurohealth LLC	ANDA	Current
58602-821	Loratadine ODT	Loratadine	Aurohealth LLC	ANDA	Current
58602-821	Loratadine ODT	Loratadine	Aurohealth LLC	ANDA	Current
58602-821	Loratadine ODT	Loratadine	Aurohealth LLC	ANDA	Current
58602-830	Loratadine ODT	Loratadine	Aurohealth LLC	ANDA	Current
58602-830	Loratadine ODT	Loratadine	Aurohealth LLC	ANDA	Current
58602-830	Loratadine ODT	Loratadine	Aurohealth LLC	ANDA	Current
58602-881	Loratadine ODT	Loratadine	Aurohealth LLC	ANDA	Current
60000-950	Loratadine ODT	Loratadine	Ahold U.S.A., Inc,	ANDA	Current
60000-950	Loratadine ODT	Loratadine	Ahold U.S.A., Inc,	ANDA	Current
60000-950	Loratadine ODT	Loratadine	Ahold U.S.A., Inc,	ANDA	Current
68016-088	Loratadine ODT	Loratadine	Chain Drug Consortium, LLC	ANDA	Current
68016-088	Loratadine ODT	Loratadine	Chain Drug Consortium, LLC	ANDA	Current
68016-088	Loratadine ODT	Loratadine	Chain Drug Consortium, LLC	ANDA	Current
69842-085	Loratadine ODT	Loratadine	CVS Pharmacy, Inc.	ANDA	Current
69842-085	Loratadine ODT	Loratadine	CVS Pharmacy, Inc.	ANDA	Current
69842-085	Loratadine ODT	Loratadine	CVS Pharmacy, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72836	SUPPL	2022-12-09