Application 076050

Type: ANDA
Sponsor: PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	5MG;120MG	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
A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2003-01-30

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	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`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 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief D	LORATADINE, PSEUDOEPHEDRINE SULFATE	Rite Aid Corporation	f08ebf00-a1d7-4a6f-a84f-195d000de53d	2026-09-04	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
perrigo allergy d	LORATADINE, PSEUDOEPHEDRINE SULFATE	L. Perrigo Company	955c9f49-38af-4b48-b325-60fa94bfe60b	2026-09-01	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
allergy and nasal congestion	LORATADINE, PSEUDOEPHEDRINE SULFATE	Kroger Company	934dda74-7995-46f1-b6f2-f4b928a2eeb2	2026-07-08	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
allergy relief d 12	LORATADINE, PSEUDOEPHEDRINE SULFATE	Walgreen Company	7e6ea563-cc79-4683-b600-0691e0fb78ab	2026-04-09	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
allergy relief d 12	LORATADINE, PSEUDOEPHEDRINE SULFATE	CVS Pharmacy	0ca2b074-7137-478c-b32c-67f834f6c454	2026-03-15	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050 ndc (product): 69842-641
loratadine D	LORATADINE, PSEUDOEPHEDRINE SULFATE	Sportpharm LLC	bb54f613-b2ab-48fd-83c9-2038ec7097f6	2026-02-06	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
good neighbor pharmacy loratadine d	LORATADINE, PSEUDOEPHEDRINE SULFATE	Amerisource Bergen	90b0a155-b92c-45e3-959f-8f21065d31dd	2025-09-12	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
equate allergy and congestion relief	LORATADINE, PSEUDOEPHEDRINE SULFATE	Wal-Mart Stores Inc	306e8736-b27f-4445-b613-3e5b609f8d42	2025-07-17	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
foster and thrive allergy D 12 hour	LORATADINE, PSEUDOEPHEDRINE SULFATE	Strategic Sourcing Services LLC	4626e3ca-d3e9-46ad-9c53-66d27c82aed7	2025-06-13	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
allergy relief d	LORATADINE, PSEUDOEPHEDRINE SULFATE	Meijer Distribution Inc	dd19215c-0da7-483a-88e3-6a32ac210c4c	2025-05-28	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
loratadine D	LORATADINE, PSEUDOEPHEDRINE SULFATE	Padagis Israel Pharmaceuticals Ltd	01e61c73-3b81-4683-b1a9-8784c0d565b1	2025-03-03	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
Allergy and Congestion Relief	LORATADINE, PSEUDOEPHEDRINE SULFATE	L. Perrigo Company	b5589371-48bc-44a5-bcab-018a92e22796	2024-02-26	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
kirkland signature allerclear d 12 hr	LORATADINE, PSEUDOEPHEDRINE SULFATE	Costco Wholesale Company	1534720b-f8f8-4db5-99e0-cfa49acf9299	2023-07-07	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
topcare allergy and congestion relief	LORATADINE, PSEUDOEPHEDRINE SULFATE	Topco Associates LLC	dd93d172-2a3a-4e4c-a237-7668acbd537d	2022-02-16	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
Alavert Allergy and Congestion D-12 hour	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Foundation Consumer Brands	1a669f3c-36a6-439e-843d-47638fa217e8	2021-12-07	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050 ndc (product): 80070-100
Leader Allergy Relief D12	LORATADINE, PSEUDOEPHEDRINE SULFATE	Cardinal Health 110, LLC. dba Leader	98bd6186-2bd2-4f46-99df-f509bb00e03a	2021-06-17	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050 ndc (product): 70000-0504
signature care allergy and congestion relief	LORATADINE, PSEUDOEPHEDRINE SULFATE	Safeway	e1993d05-248e-48da-838c-068f8263c2eb	2021-03-08	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
allergy relief d	LORATADINE, PSEUDOEPHEDRINE SULFATE	Publix Super Markets Inc	8209d7d5-4ecc-4170-ba50-5917bd8c46d4	2020-10-19	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050

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 2 of 2 · 94 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69256-257	Harris Teeter Allergy and Congestion Relief	loratadine, Pseudoephedrine sulfate	Harris Teeter, LLC	ANDA	Current
69256-257	Harris Teeter Allergy and Congestion Relief	loratadine, Pseudoephedrine sulfate	Harris Teeter, LLC	ANDA	Current
69842-641	allergy relief d 12	loratadine, Pseudoephedrine sulfate	CVS Pharmacy	ANDA	Current
69842-641	allergy relief d 12	loratadine, Pseudoephedrine sulfate	CVS Pharmacy	ANDA	Current
69842-641	allergy relief d 12	loratadine, Pseudoephedrine sulfate	CVS Pharmacy	ANDA	Current
70000-0504	Leader Allergy Relief D12	loratadine, Pseudoephedrine sulfate	Cardinal Health	ANDA	Current
70000-0504	Leader Allergy Relief D12	loratadine, Pseudoephedrine sulfate	Cardinal Health	ANDA	Current
70000-0504	Leader Allergy Relief D12	loratadine, Pseudoephedrine sulfate	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70677-0036	sunmark loratadine d	loratadine, Pseudoephedrine sulfate	McKesson	ANDA	Current
70677-0036	sunmark loratadine d	loratadine, Pseudoephedrine sulfate	Strategic Sourcing Services LLC	ANDA	Current
70677-0036	sunmark loratadine d	loratadine, Pseudoephedrine sulfate	Strategic Sourcing Services LLC	ANDA	Current
70677-0036	sunmark loratadine d	loratadine, Pseudoephedrine sulfate	McKesson	ANDA	Current
80070-100	Alavert	LORATADINE and PSEUDOEPHEDRINE SULFATE	Foundation Consumer Brands	ANDA	Current
80159-301	picnic nasal decongestant and antihistamine	loratadine, Pseudoephedrine sulfate	30M One, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22531	ORIG	2012-03-28
31065	ORIG	2004-06-08