Application 213294

Type: ANDA
Sponsor: TENSHI

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
A213294-001	LORATADINE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2020-10-30

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
2026-02-19 14:30 UTC	2026-02	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`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 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allervarx	LORATADINE	Innovus Pharmaceuticals, Inc.	885e81ae-5ea3-4d14-8666-8c2698767014	2024-12-27	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294 ndc (product): 57483-950
Alavert Allergy	LORATADINE	Foundation Consumer Healthcare	1704474a-9b99-de45-e063-6294a90ac59b	2024-06-24	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294
LORATADINE	LORATADINE	Tenshi Kaizen Pvt Ltd	9c168fbb-6668-4a9d-9c7e-d3441e60eb95	2024-05-07	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294
Alavert Allergy	LORATADINE	Foundation Consumer Healthcare	15c3f848-fef6-433b-e063-6394a90abd2b	2024-05-01	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294
LORATADINE	LORATADINE	CVS PHARMACY, INC	7ed2aec0-4da7-4edc-9998-b96c67c82738	2024-01-02	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294 ndc (product): 51316-503
LORATADINE	LORATADINE	Strides Pharma Inc	16ab6610-ac99-4714-848d-9377c6bca459	2024-01-02	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294 ndc (product): 59556-917
LORATADINE	LORATADINE	Tenshi Kaizen Pvt Ltd	c20b916d-7dd0-1a56-e053-2995a90a3c1b	2024-01-02	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294 ndc (product): 72983-501
LORATADINE	LORATADINE	Dr. Reddy's Laboratories Inc.	d707733d-1ee9-92d3-f5b2-3567b9c217c2	2023-06-25	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294
LORATADINE	LORATADINE	Dr. Reddy's Laboratories Inc.	bb6af6a4-aec0-ddf5-57b7-063504ca8e1e	2023-06-25	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51316-503	LORATADINE	LORATADINE	CVS PHARMACY, INC	ANDA	Current
51316-503	LORATADINE	LORATADINE	CVS PHARMACY, INC	ANDA	Current
51316-503	LORATADINE	LORATADINE	CVS PHARMACY, INC	ANDA	Current
51316-503	LORATADINE	LORATADINE	CVS PHARMACY, INC	ANDA	Current
57483-950	Allervarx	Loratadine	Innovus Pharmaceuticals, Inc.	ANDA	Current
59556-917	LORATADINE	LORATADINE	Strides Pharma Inc	ANDA	Current
59556-917	LORATADINE	LORATADINE	Strides Pharma Inc	ANDA	Current
59556-917	LORATADINE	LORATADINE	Strides Pharma Inc	ANDA	Current
72983-501	LORATADINE	LORATADINE	Tenshi Kaizen Pvt Ltd	ANDA	Current
72983-501	LORATADINE	LORATADINE	Tenshi Kaizen Pvt Ltd	ANDA	Current