Application 075209

Type: ANDA
Sponsor: PLD ACQUISITIONS LLC

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 43.

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
A075209-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2003-01-21

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`f41ea6bd6efb…`

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
All Day Allergy Relief	LORATADINE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	9ea4fde8-e091-412d-9de1-dd66a2ab73e4	2023-10-26	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Loratadine	LORATADINE	PLD Acquisitions LLC DBA Avma Pharma Solutions	2edb53f8-7661-4e54-bb50-e03078bae3bf	2023-05-04	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209 ndc (product): 63548-0753
Indoor Outdoor Allergy Relief	LORATADINE	Walgreens	19fb573f-29a1-4166-becb-0698cfbb682c	2022-11-30	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209 ndc (product): 0363-0858

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 90 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0858	Indoor Outdoor Allergy Relief	Loratadine	Walgreens	ANDA	Current
0363-0858	Indoor Outdoor Allergy Relief	Loratadine	Walgreens	ANDA	Current
0363-0858	Indoor Outdoor Allergy Relief	Loratadine	Walgreens	ANDA	Current
0363-9150	Wal-itin	Loratadine	Walgreens	ANDA	Current
0363-9150	Wal-itin	Loratadine	Walgreens	ANDA	Current
0363-9150	Wal-itin	Loratadine	Walgreens	ANDA	Current
0363-9150	Wal-itin	Loratadine	Walgreens	ANDA	Current
0363-9150	Wal-itin	Loratadine	Walgreens	ANDA	Current
0615-5586	Loratadine	Loratadine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-5586	Loratadine	Loratadine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0781-5077	Loratadine	Loratadine	Sandoz Inc	ANDA	Current
11523-0800	Claritin	loratadine	Bayer HealthCare LLC.	ANDA	Current
11523-0800	Claritin	loratadine	Bayer HealthCare LLC.	ANDA	Current
11822-3276	Allergy Relief	Loratadine	Rite Aid Corporation	ANDA	Current
11822-3276	Allergy Relief	Loratadine	Rite Aid Corporation	ANDA	Current
11822-3276	Allergy Relief	Loratadine	Rite Aid Corporation	ANDA	Current
11822-3276	Allergy Relief	Loratadine	Rite Aid Corporation	ANDA	Current
16714-482	Loratadine	Loratadine	Northstar RxLLC	ANDA	Current
49035-260	Loratadine	Loratadine	Wal-Mart	ANDA	Current
49348-112	Loratadine	Loratadine	Sunmark	ANDA	Current
50090-3464	Loratadine	Loratadine	A-S Medication Solutions	ANDA	Current
50090-3620	Loratadine	Loratadine	A-S Medication Solutions	ANDA	Current
50090-3620	Loratadine	Loratadine	A-S Medication Solutions	ANDA	Current
50090-4148	Allergy Relief	Loratadine	A-S Medication Solutions	ANDA	Current
50090-4148	Allergy Relief	Loratadine	A-S Medication Solutions	ANDA	Current
50090-4148	Allergy Relief	Loratadine	A-S Medication Solutions	ANDA	Current
50090-4148	Allergy Relief	Loratadine	A-S Medication Solutions	ANDA	Current
50090-4266	Allergy Relief	Loratadine	A-S Medication Solutions	ANDA	Current
50090-5067	Allergy Relief	Loratadine	A-S Medication Solutions	ANDA	Current
50090-6164	Allergy relief	Loratadine	A-S Medication Solutions	ANDA	Current
54473-166	CounterAct	Loratadine	Melaleuca, Inc.	ANDA	Current
57896-658	Allergy relief	Loratadine	Geri-Care Pharmaceutical Corp	ANDA	Current
57896-658	Allergy relief	Loratadine	Geri-Care Pharmaceutical Corp	ANDA	Current
57896-687	Allergy relief	Loratadine	Geri-Care Pharmaceutical Corp	ANDA	Current
57896-687	Allergy relief	Loratadine	Geri-Care Pharmaceutical Corp	ANDA	Current
59726-758	All Day Allergy Relief	Loratadine	P & L Development, LLC	ANDA	Current
59726-758	All Day Allergy Relief	Loratadine	P & L Development, LLC	ANDA	Current
59726-758	All Day Allergy Relief	Loratadine	P & L Development, LLC	ANDA	Current
59726-915	All Day Allergy Relief	Loratadine	P & L Development, LLC	ANDA	Current
59726-915	All Day Allergy Relief	Loratadine	P & L Development, LLC	ANDA	Current
59726-915	All Day Allergy Relief	Loratadine	P & L Development, LLC	ANDA	Current
60760-569	Allergy Relief	Loratadine	St Mary's Medical Park Pharmacy	ANDA	Current
60760-650	Loratadine	Loratadine	St. Mary	ANDA	Current
62011-0258	Loratadine	Loratadine	HealthMart	ANDA	Current
63548-0753	Loratadine	Loratadine	PLD Acquisitions LLC DBA Av	ANDA	Current
63548-0753	Loratadine	Loratadine	PLD Acquisitions LLC DBA Av	ANDA	Current
63654-407	Allergy Relief	Loratadine	Selder, S.A. de C.V.	ANDA	Current
63868-414	Allergy Relief	Loratadine	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-414	Allergy Relief	Loratadine	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-462	Allergy Relief	Loratadine	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-462	Allergy Relief	Loratadine	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-462	Allergy Relief	Loratadine	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-577	Allergy Relief	Loratadine	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-577	Allergy Relief	Loratadine	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
66715-9742	Claritin	loratadine tablet	Lil' Drug Store Products, Inc.	ANDA	Current
67046-453	Loratadine	Loratadine	Contract Pharmacy Services-PA	ANDA	Current
67091-350	Allergy Relief	Loratadine	WinCo Foods, LLC	ANDA	Current
67091-350	Allergy Relief	Loratadine	WinCo Foods, LLC	ANDA	Current
68071-2208	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2208	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2208	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2208	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2208	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2392	Loratadine	Loratadine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3203	Loratadine	Loratadine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-7769	Allergy Relief	Loratadine	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7769	Allergy Relief	Loratadine	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7769	Allergy Relief	Loratadine	Preferred Pharmaceuticals, Inc.	ANDA	Current
69168-407	Allergy Relief	Loratadine	Allegiant Health	ANDA	Current
69230-312	Allergy Relief	Loratadine	Camber Consumer Care	ANDA	Current
69230-312	Allergy Relief	Loratadine	Camber Consumer Care	ANDA	Current
69230-312	Allergy Relief	Loratadine	Camber Consumer Care	ANDA	Current
69230-312	Allergy Relief	Loratadine	Camber Consumer Care	ANDA	Current
69230-317	Allergy Relief	Loratadine	Camber Consumer Care	ANDA	Current
69230-317	Allergy Relief	Loratadine	Camber Consumer Care	ANDA	Current
69230-317	Allergy Relief	Loratadine	Camber Consumer Care	ANDA	Current
70518-0325	Loratadine	Loratadine	REMEDYREPACK INC.	ANDA	Current
70518-0325	Loratadine	Loratadine	REMEDYREPACK INC.	ANDA	Current
70677-0145	All Day Allergy Relief	Loratadine	Strategic Sourcing Services LLC	ANDA	Current
70677-0145	All Day Allergy Relief	Loratadine	Strategic Sourcing Services LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8565	ORIG	2003-07-24