Application 077946

Type: ANDA
Sponsor: PLD ACQUISITIONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL			2007-12-27
A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL			2007-12-27

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077946-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077946-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`3a93d1ddd44b…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
All Day Allergy Relief	CETIRIZINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	76ec3257-9206-4a0f-a2cf-8a05217b92e7	2025-07-01	Warnings	Exact identifier application applno (ANDA): 077946 application number: ANDA077946 ndc (product): 55910-039
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sandoz Inc	760dd0e4-280a-4d95-8938-cecaa7ec75f2	2013-06-03	Warnings	Exact identifier application applno (ANDA): 077946 application number: ANDA077946 ndc (product): 0781-1684

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 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7522	Cetirizine	Cetirizine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0781-1683	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1683	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1684	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1684	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Sandoz Inc	ANDA	Current
21695-709	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Rebel Distributors Corp	ANDA	Current
52959-923	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	H. J. Harkins Company Inc.	ANDA	Current
55910-039	All Day Allergy Relief	Cetirizine HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-039	All Day Allergy Relief	Cetirizine HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-039	All Day Allergy Relief	Cetirizine HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
59726-739	All Day Allergy	Cetirizine HCL	P & L Development, LLC	ANDA	Current
59726-739	All Day Allergy	Cetirizine HCL	P & L Development, LLC	ANDA	Current
62011-0408	All Day Allergy	Cetirizine HCL	McKesson (Health Mart)	ANDA	Current
63548-0739	Indoor outdoor allergies	Cetirizine HCl	PLD Acquisitions LLC DBA Av	ANDA	Current
66336-336	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Dispensing Solutions, Inc.	ANDA	Current
68788-6905	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6905	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0664	Cetirizine Hydrochloride	Cetirizine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0777	Cetirizine Hydrochloride	Cetirizine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0028	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0028	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9098	ORIG	2008-01-09
39544	ORIG	2008-01-08