Application 076011

Type: ANDA
Sponsor: PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORATADINE	LORATADINE	TABLET, ORALLY DISINTEGRATING;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
A076011-001	LORATADINE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2003-09-29

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 · 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	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLERGY RELIEF	LORATADINE	Meijer, Inc.	190ecdc3-454a-4623-9e4a-09f4ab865084	2026-07-09	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
allergy relief	LORATADINE	Kroger Company	745d48f2-504d-4e3d-abf8-768d201cf814	2026-02-24	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 30142-446
equate loratadine	LORATADINE	WALMART INC.	882dc99b-22d2-4f3e-8613-9ac8d9c5d910	2025-10-14	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
ALLERGY RELIEF	LORATADINE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	31cb3c06-7e15-4000-b169-50b66c14b01b	2025-10-06	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
non drowsy allergy relief	LORATADINE	Meijer Distribution Inc	4762c96e-d562-4f74-a275-8cba597987f9	2025-05-08	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 41250-890
Basic Care Allergy Relief	LORATADINE	Amazon.com Services LLC	76e35b3f-3382-4e14-a25f-5544c75ff7c8	2024-11-05	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 72288-451
loratadine	LORATADINE	Rite Aid Corporation	004dd408-e3ff-4ba6-b859-beebe364f0e1	2023-11-09	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 11822-0919
loratadine	LORATADINE	Rite Aid Corporation	7b804f66-9323-4119-a856-1e6f08280781	2023-11-05	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 11822-0558
dg health allergy relief	LORATADINE	Dolgencorp, LLC	04258018-3d57-46d7-9595-04786da3f51a	2022-10-13	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 55910-970
signature care allergy relief	LORATADINE	Safeway	0a4b8eef-762e-42cc-84ee-0018a9a3be58	2022-04-04	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 21130-452
Topcare Allergy Relief	LORATADINE	Topco Associates LLC	32f4e1d1-c830-4752-8251-bcc233bf03f6	2021-11-29	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 36800-853
careone allergy relief	LORATADINE	American Sales Company	fdacfd88-eb85-4a33-9863-c6ff484fea4e	2021-11-15	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 41520-510
good sense allergy relief	LORATADINE	L. Perrigo Company	a8f97128-3af8-493d-8e66-a1e07f594131	2021-07-14	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 0113-1191
dg health allergy relief	LORATADINE	Dolgencorp, LLC	c18c40ae-19c8-4699-842a-43a5c4c236d5	2021-06-22	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 55910-594
good sense allergy relief	LORATADINE	L. Perrigo Company	3ef968b8-6732-4c80-b385-f471ed407817	2021-03-15	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 0113-9755
Basic Care Allergy Relief	LORATADINE	Amazon.com Services LLC	c22c9880-ed0e-48a7-a30e-41f0aed5a212	2020-09-03	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 72288-200

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-1191	good sense allergy relief	loratadine	L. Perrigo Company	ANDA	Current
0113-1191	good sense allergy relief	loratadine	L. Perrigo Company	ANDA	Current
0113-9755	good sense allergy relief	loratadine	L. Perrigo Company	ANDA	Current
11822-0558	loratadine	loratadine	Rite Aid Corporation	ANDA	Current
11822-0558	loratadine	loratadine	Rite Aid Corporation	ANDA	Current
11822-0919	loratadine	loratadine	Rite Aid Corporation	ANDA	Current
21130-301	signature care allergy relief	loratadine	Safeway	ANDA	Current
21130-301	signature care allergy relief	loratadine	Safeway	ANDA	Current
21130-452	signature care allergy relief	loratadine	Safeway	ANDA	Current
30142-446	allergy relief	loratadine	Kroger Company	ANDA	Current
36800-853	Topcare Allergy Relief	loratadine	Topco Associates LLC	ANDA	Current
36800-853	Topcare Allergy Relief	loratadine	Topco Associates LLC	ANDA	Current
41250-890	non drowsy allergy relief	loratadine	Meijer Distribution Inc	ANDA	Current
41520-510	careone allergy relief	loratadine	American Sales Company	ANDA	Current
55910-594	dg health allergy relief	loratadine	Dolgencorp, LLC	ANDA	Current
55910-970	dg health allergy relief	loratadine	Dolgencorp, LLC	ANDA	Current
55910-970	dg health allergy relief	loratadine	Dolgencorp, LLC	ANDA	Current
72288-200	Basic Care Allergy Relief	loratadine	Amazon.com Services LLC	ANDA	Current
72288-451	Basic Care Allergy Relief	loratadine	Amazon.com Services LLC	ANDA	Current