Application 076301

Type: ANDA
Sponsor: PERRIGO

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
A076301-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2004-06-25

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	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`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 3 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
welby all day allergy relief	LORATADINE	Aldi, Inc	efe2fa11-8115-4d33-bb32-8e2509839ef4	2021-06-22	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine	LORATADINE	Aphena Pharma Solutions - Tennessee, LLC	8ffe2faf-3253-4121-a069-6f46e319c6f0	2020-05-13	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	L. Perrigo Company	74bed4ad-5afe-4293-bef3-e0b9d5f64a29	2019-12-05	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301 ndc (product): 0113-1612

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 207 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0612	good sense allergy relief	Loratadine	L. Perrigo Company	ANDA	Current
0113-0612	good sense allergy relief	Loratadine	L. Perrigo Company	ANDA	Current
0113-0612	good sense allergy relief	Loratadine	L. Perrigo Company	ANDA	Current
0113-0612	good sense allergy relief	Loratadine	L. Perrigo Company	ANDA	Current
0113-1612	good sense allergy relief	Loratadine	L. Perrigo Company	ANDA	Current
0113-1612	good sense allergy relief	Loratadine	L. Perrigo Company	ANDA	Current
0113-7612	Basic Care allergy relief	Loratadine	L. Perrigo Company	ANDA	Current
0113-7612	Basic Care allergy relief	Loratadine	L. Perrigo Company	ANDA	Current
0363-0699	Wal itin	Loratadine	Walgreen Company	ANDA	Current
0363-1612	allergy relief	Loratadine	Walgreen Company	ANDA	Current
0363-1612	allergy relief	Loratadine	Walgreen Company	ANDA	Current
0363-1612	allergy relief	Loratadine	Walgreen Company	ANDA	Current
0615-8217	Loratadine	Loratadine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8217	Loratadine	Loratadine	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0904-5728	allergy	Loratadine	Major Pharmaceuticals	ANDA	Current
0904-5728	allergy	Loratadine	Major Pharmaceuticals	ANDA	Current
0904-5728	allergy	Loratadine	Major Pharmaceuticals	ANDA	Current
0904-6852	Loratadine	Loratadine	Major Pharmaceuticals	ANDA	Current
0904-6852	Loratadine	Loratadine	Major Pharmaceuticals	ANDA	Current
0904-6852	Loratadine	Loratadine	Major Pharmaceuticals	ANDA	Current
0904-6852	Loratadine	Loratadine	Major Pharmaceuticals	ANDA	Current
0904-6852	Loratadine	Loratadine	Major Pharmaceuticals	ANDA	Current
10202-612	7 Select Allergy Relief	Loratadine	7-Eleven	ANDA	Current
10202-612	7 Select Allergy Relief	Loratadine	7-Eleven	ANDA	Current
11673-612	up and up allergy relief	Loratadine	Target Corporation	ANDA	Current
11673-612	up and up allergy relief	Loratadine	Target Corporation	ANDA	Current
11822-0612	allergy relief	Loratadine	Rite Aid Corporation	ANDA	Current
11822-0612	allergy relief	Loratadine	Rite Aid Corporation	ANDA	Current
11822-0612	allergy relief	Loratadine	Rite Aid Corporation	ANDA	Current
16714-898	Loratadine	Loratadine	Northstar RxLLC	ANDA	Current
16714-898	Loratadine	Loratadine	Northstar RxLLC	ANDA	Current
21130-123	Signature Care Allergy Relief	Loratadine	Safeway	ANDA	Current
21130-123	Signature Care Allergy Relief	Loratadine	Safeway	ANDA	Current
24385-471	good neighbor pharmacy loratadine	Loratadine	Amerisource Bergen	ANDA	Current
24385-471	good neighbor pharmacy loratadine	Loratadine	Amerisource Bergen	ANDA	Current
30142-612	Allergy Relief	Loratadine	Kroger Company	ANDA	Current
30142-612	Allergy Relief	Loratadine	Kroger Company	ANDA	Current
30142-612	Allergy Relief	Loratadine	Kroger Company	ANDA	Current
33992-0612	Assured Allergy Relief	Loratadine	Greenbrier International Inc.	ANDA	Current
35356-881	Loratadine	Loratadine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-881	Loratadine	Loratadine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
36800-612	TopCare Allergy Relief	Loratadine	Topco Associates LLC	ANDA	Current
36800-612	TopCare Allergy Relief	Loratadine	Topco Associates LLC	ANDA	Current
36800-612	TopCare Allergy Relief	Loratadine	Topco Associates LLC	ANDA	Current
36800-929	topcare clear time	Loratadine	Topco Associates LLC	ANDA	Current
37012-612	Allergy Relief	Loratadine	Shopko Stores Operating Co., LLC	ANDA	Current
37012-612	Allergy Relief	Loratadine	Shopko Stores Operating Co., LLC	ANDA	Current
41163-612	Equaline Allergy Relief	Loratadine	Supervalu Inc	ANDA	Current
41163-612	Equaline Allergy Relief	Loratadine	Supervalu Inc	ANDA	Current
41163-612	Equaline Allergy Relief	Loratadine	Supervalu Inc	ANDA	Current
41190-612	ShopRite Allergy Relief	Loratadine	Wakefern Food Corporation	ANDA	Current
41190-612	ShopRite Allergy Relief	Loratadine	Wakefern Food Corporation	ANDA	Current
41250-523	allergy relief	Loratadine	Meijer Distribution Inc	ANDA	Current
41250-523	allergy relief	Loratadine	Meijer Distribution Inc	ANDA	Current
41250-612	allergy relief	Loratadine	Meijer Distribution Inc	ANDA	Current
41520-612	CareOne Allergy Relief	Loratadine	American Sales Company	ANDA	Current
41520-612	CareOne Allergy Relief	Loratadine	American Sales Company	ANDA	Current
41520-612	CareOne Allergy Relief	Loratadine	American Sales Company	ANDA	Current
43353-259	Loratadine	Loratadine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-259	Loratadine	Loratadine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-259	Loratadine	Loratadine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-259	Loratadine	Loratadine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
45802-650	Loratadine	Loratadine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-650	Loratadine	Loratadine	Perrigo New York Inc	ANDA	Current
45802-650	Loratadine	Loratadine	Perrigo New York Inc	ANDA	Current
46994-612	Being Well Allergy Relief	Loratadine	Save-A-Lot Food Stores Ltd	ANDA	Current
46994-612	Being Well Allergy Relief	Loratadine	Save-A-Lot Food Stores Ltd	ANDA	Current
46994-612	Being Well Allergy Relief	Loratadine	Save-A-Lot Food Stores Ltd	ANDA	Current
49035-612	equate allergy relief	Loratadine	Wal-Mart Stores Inc	ANDA	Current
49035-612	equate allergy relief	Loratadine	Wal-Mart Stores Inc	ANDA	Current
49035-612	equate allergy relief	Loratadine	Wal-Mart Stores Inc	ANDA	Current
49348-394	SUNMARK LORATADINE	Loratadine	Mckesson	ANDA	Current
49348-394	SUNMARK LORATADINE	Loratadine	Strategic Sourcing Services LLC	ANDA	Current
49348-818	Sunmark Loratadine	Loratadine	McKesson	ANDA	Current
49348-818	Sunmark Loratadine	Loratadine	Strategic Sourcing Services LLC	ANDA	Current
49348-818	Sunmark Loratadine	Loratadine	Strategic Sourcing Services LLC	ANDA	Current
49348-818	Sunmark Loratadine	Loratadine	Strategic Sourcing Services LLC	ANDA	Current
49349-218	Loratadineantihistamine	Loratadine	REMEDYREPACK INC.	ANDA	Current
49738-612	Smart Sense Allergy Relief	Loratadine	Kmart Corporation	ANDA	Current
50090-0836	Loratadine	Loratadine	A-S Medication Solutions	ANDA	Current