Application 212795

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	5MG	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
A212795-001	LORATADINE	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2020-09-18

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.

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	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LORATADINE	LORATADINE	CVS PHARMACY, INC	4e74e322-7f6e-467c-96c0-9b531ddb429b	2024-12-31	Warnings	Exact identifier application applno (ANDA): 212795 application number: ANDA212795 ndc (product): 51316-502
Allervarx	LORATADINE	Innovus Pharmaceuticals, Inc.	ec4d1e77-6995-4228-8e63-a9ab6232dace	2024-12-27	Warnings	Exact identifier application applno (ANDA): 212795 application number: ANDA212795 ndc (product): 57483-955
Loratadine	LORATADINE	Tenshi Kaizen Pvt Ltd	c20b91e0-ef92-6f2f-e053-2a95a90a2a36	2024-01-02	Warnings	Exact identifier application applno (ANDA): 212795 application number: ANDA212795 ndc (product): 72983-500
LORATADINE	LORATADINE	Strides Pharma Inc	a54cdbe9-32ec-45ca-948f-9cefbb8e3cbf	2024-01-02	Warnings	Exact identifier application applno (ANDA): 212795 application number: ANDA212795 ndc (product): 59556-301
Loratadine	LORATADINE	Walgreens Company	8229ca40-31cf-3dbd-078d-364f5674cb21	2023-02-27	Warnings	Exact identifier application applno (ANDA): 212795 application number: ANDA212795
Loratadine	LORATADINE	Dr. Reddy's Laboratories Inc.	9357186a-9452-e139-01d8-6b8c6f6a2c6b	2023-02-24	Warnings	Exact identifier application applno (ANDA): 212795 application number: ANDA212795

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51316-502	LORATADINE	LORATADINE	CVS PHARMACY, INC	ANDA	Current
57483-955	Allervarx	Loratadine	Innovus Pharmaceuticals, Inc.	ANDA	Current
59556-301	LORATADINE	LORATADINE	Strides Pharma Inc	ANDA	Current
59556-301	LORATADINE	LORATADINE	Strides Pharma Inc	ANDA	Current
59556-301	LORATADINE	LORATADINE	Strides Pharma Inc	ANDA	Current
72983-500	Loratadine	Loratadine	Tenshi Kaizen Pvt Ltd	ANDA	Current
72983-500	Loratadine	Loratadine	Tenshi Kaizen Pvt Ltd	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65101	ORIG	2020-10-30