Application 077421

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORATADINE	LORATADINE	SYRUP;ORAL	1MG/ML	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
A077421-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2006-06-29

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	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	ATLANTIC BIOLOGICALS CORP.	999a1080-5bbd-4027-b6e7-a90a6941ee27	2026-02-26	Warnings	Exact identifier application applno (ANDA): 077421 application number: ANDA077421 ndc (product): 17856-0557
Loratadine	LORATADINE	Lannett Company, Inc.	069c4e75-1f9f-4ab5-9570-3d93d12c2a23	2025-06-19	Warnings	Exact identifier application applno (ANDA): 077421 application number: ANDA077421 ndc (product): 54838-558 ndc (product): 54838-554
Loratadine	LORATADINE	NuCare Pharmaceuticals,Inc.	6d0c0948-9288-9bb8-e053-2a91aa0abf3a	2024-06-10	Warnings	Exact identifier application applno (ANDA): 077421 application number: ANDA077421 ndc (product): 68071-4451
Loratadine	LORATADINE	A-S Medication Solutions	0f6fe391-8709-40f0-8f52-e3357e6ea4f9	2023-12-09	Warnings	Exact identifier application applno (ANDA): 077421 application number: ANDA077421 ndc (product): 50090-1454

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0849	Childrens Loratadine	LORATADINE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0849	Childrens Loratadine	LORATADINE	Pharmaceutical Associates, Inc.	ANDA	Current
0904-6234	Loratadine	Loratadine	Major Pharmaceuticals, Inc	ANDA	Current
11673-039	Childrens Allergy	Loratadine	TARGET Corporation	ANDA	Current
11673-039	Childrens Allergy	Loratadine	TARGET Corporation	ANDA	Current
17856-0557	Loratadine	Loratadine	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0557	Loratadine	Loratadine	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-6234	Loratadine	Loratadine	Atlantic Biologicals Corps	ANDA	Current
41250-539	Allergy	Loratadine	MEIJER, INC.	ANDA	Current
41250-539	Allergy	Loratadine	MEIJER, INC.	ANDA	Current
41250-539	Allergy	Loratadine	MEIJER, INC.	ANDA	Current
50090-1454	Loratadine	Loratadine	A-S Medication Solutions	ANDA	Current
50090-1454	Loratadine	Loratadine	A-S Medication Solutions	ANDA	Current
50090-1454	Loratadine	Loratadine	A-S Medication Solutions	ANDA	Current
54838-554	Loratadine	Loratadine	Lannett Company, Inc.	ANDA	Current
54838-554	Loratadine	Loratadine	Lannett Company, Inc.	ANDA	Current
54838-558	Loratadine	Loratadine	Lannett Company, Inc.	ANDA	Current
54838-558	Loratadine	Loratadine	Lannett Company, Inc.	ANDA	Current
55910-539	Childrens Allergy	Loratadine	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-539	Childrens Allergy	Loratadine	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
63868-096	Childrens Allergy	Loratadine	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-096	Childrens Allergy	Loratadine	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
68071-4121	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4121	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4121	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4451	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4451	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4451	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4451	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7291	Loratadine	Loratadine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7291	Loratadine	Loratadine	preferred Pharmaceuticals Inc.	ANDA	Current
68788-7291	Loratadine	Loratadine	preferred Pharmaceuticals Inc.	ANDA	Current
68788-7291	Loratadine	Loratadine	preferred Pharmaceuticals Inc.	ANDA	Current
68788-9805	Loratadine	Loratadine	Preferred Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9043	ORIG	2006-07-13