Application 214684

Type: ANDA
Sponsor: UNIQUE PHARM

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 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
A214684-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2021-01-07

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.

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	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`a50c72e98297…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	NuCare Pharmaceuticals, Inc.	569a35be-d653-181c-e063-6294a90a6eb9	2026-07-14	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Loratadine	LORATADINE	Preferred Pharmaceuticals Inc	0a0d700d-bdba-4c90-a947-5d61d40ce4df	2026-05-28	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
ValuMeds Allergy Relief Loratadine	LORATADINE	Cabinet Health P.B.C.	43bc8e38-bd74-411c-b4fe-7d809d24ae46	2026-05-20	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Loratadine	LORATADINE	Strategic Sourcing Services, LLC	a527f83a-4ae9-47b1-94e0-7ab3148b025f	2026-01-29	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Loratadine	LORATADINE	Cabinet Health P.B.C.	8b090fa2-9535-456c-b14d-187a2873cdf7	2025-10-27	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
CVS Loratadine	LORATADINE	CVS Pharmacy	3d716988-da63-59e6-e063-6394a90a5b4b	2025-10-22	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Nuvicare-Allergy Relief Loratadine Tablets, 10 mg	LORATADINE	NUVICARE LLC	023a46f0-8d1c-4f62-953d-3e6458a54f6e	2025-07-01	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Gencare-Allergy Relief Loratadine Tablets, 10 mg	LORATADINE	Pioneer Life Sciences, LLC	647dc957-4aee-48f6-bb77-e82d3b380e80	2025-06-30	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Loratadine	LORATADINE	Gobrands, Inc	1d182bd6-ad72-4352-b983-407a48c317f0	2025-01-25	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684 ndc (product): 82501-1580
Loratadine	LORATADINE	Advanced Rx Pharmacy of Tennessee, LLC	01cb43cf-57a9-f189-e063-6294a90afd88	2024-12-31	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Loratadine	LORATADINE	Rising Pharmaceuticals, Inc	d28128a3-af54-440e-9bd4-0fccf393d18a	2022-03-10	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684 ndc (product): 16571-822

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-822	Loratadine	loratadine	Rising Pharmaceuticals, Inc	ANDA	Current
68210-4126	Loratadine	Loratadine	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4126	Loratadine	Loratadine	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4126	Loratadine	Loratadine	Spirit Pharmaceuticals LLC	ANDA	Current
70677-0134	Loratadine	Loratadine	Strategic Sourcing Services, LLC	ANDA	Current
70677-0134	Loratadine	Loratadine	Strategic Sourcing Services, LLC	ANDA	Current
70677-0134	Loratadine	Loratadine	Strategic Sourcing Services, LLC	ANDA	Current
70677-0134	Loratadine	Loratadine	Strategic Sourcing Services, LLC	ANDA	Current
70985-017	Loratadine	Loratadine	DRUG OCEAN LLC	ANDA	Current
82501-1580	Loratadine	Loratadine	Gobrands, Inc	ANDA	Current