Application 076471

Type: ANDA
Sponsor: APOTEX INC

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 42.

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
A076471-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2006-02-14

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	Apotex Corp.	679164cc-7505-7ed4-13fe-87f06cb777d8	2025-09-22	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471 ndc (product): 60505-0147
Non-Drowsy Allergy Relief	LORATADINE TABLET	Lil' Drug Store Products, Inc.	031fc3e5-b5eb-447c-e063-6294a90a13b5	2023-08-17	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471
Allergy Relief	LORATADINE	Allegiant Health	0991388a-2eb8-4913-9efc-adf411eddf3a	2018-11-08	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471 ndc (product): 69168-309
Allergy	LORATADINE	Selder, S.A. de C.V.	afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251	2016-12-22	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471 ndc (product): 63654-309

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0536-1092	LORATADINE	Loratadine	Rugby Laboratories	ANDA	Current
0536-1092	LORATADINE	Loratadine	Rugby Laboratories	ANDA	Current
0904-5793	LORATADINE	Loratadine	Major Pharmaceuticals	ANDA	Current
0904-5793	LORATADINE	Loratadine	Major Pharmaceuticals	ANDA	Current
10544-455	Loratadine	Loratadine	Blenheim Pharmacal, Inc.	ANDA	Current
24286-1568	Allergy Relief	Loratadine	DLC LABORATORIES, INC	ANDA	Current
50090-0838	Loratadine	Loratadine	A-S Medication Solutions	ANDA	Current
50090-0838	Loratadine	Loratadine	A-S Medication Solutions	ANDA	Current
50268-488	Loratadine	Loratadine	AvPAK	ANDA	Current
53117-309	Allergy Relief	Loratadine	First Aid Direct	ANDA	Current
53117-407	Allergy Relief	Loratadine	First Aid Direct	ANDA	Current
57896-788	Allergy relief	Loratadine	Geri-Care Pharmaceutical Corp	ANDA	Current
57896-788	Allergy relief	Loratadine	Geri-Care Pharmaceutical Corp	ANDA	Current
60505-0147	Loratadine	Loratadine	Apotex Corp.	ANDA	Current
60505-0147	Loratadine	Loratadine	Apotex Corp.	ANDA	Current
60505-0147	Loratadine	Loratadine	Apotex Corp.	ANDA	Current
60505-0147	Loratadine	Loratadine	Apotex Corp.	ANDA	Current
60505-4649	LORATADINE	Loratadine	Apotex Corp.	ANDA	Current
60505-4649	LORATADINE	Loratadine	Apotex Corp.	ANDA	Current
63654-309	Allergy	Loratadine	Selder, S.A. de C.V.	ANDA	Current
63654-309	Allergy	Loratadine	Selder, S.A. de C.V.	ANDA	Current
68071-4318	Allergy relief	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4318	Allergy relief	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7085	LORATADINE	Loratadine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7085	LORATADINE	Loratadine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7085	LORATADINE	Loratadine	Preferred Pharmaceuticals Inc.	ANDA	Current
68998-309	Allergy Relief	Loratadine	Marc Glassman, Inc.	ANDA	Current
68998-309	Allergy Relief	Loratadine	Marc Glassman, Inc.	ANDA	Current
68998-309	Allergy Relief	Loratadine	Marc Glassman, Inc.	ANDA	Current
68998-407	Allergy Relief	Loratadine	Marc Glassman, Inc.	ANDA	Current
69168-309	Allergy Relief	Loratadine	Allegiant Health	ANDA	Current
69168-309	Allergy Relief	Loratadine	Allegiant Health	ANDA	Current
69168-309	Allergy Relief	Loratadine	Allegiant Health	ANDA	Current
70000-0317	LORATADINE	Loratadine	Cardinal Health	ANDA	Current
70000-0317	LORATADINE	Loratadine	Cardinal Health	ANDA	Current
70518-1262	LORATADINE	Loratadine	REMEDYREPACK INC.	ANDA	Current
70518-1262	LORATADINE	Loratadine	REMEDYREPACK INC.	ANDA	Current