Application 078780

Type: ANDA
Sponsor: AMNEAL PHARMS NY

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 HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
004	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-01-21
A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-01-21
A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-01-21
A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-01-21

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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief All Day	CETIRIZINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	27548729-7e2e-44cd-9a1d-70744f8b1df6	2025-07-01	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780 ndc (product): 55910-129
Cetirizine Hydrochloride Hives Relief	CETIRIZINE	Amneal Pharmaceuticals LLC	aad39214-5bf1-427b-a00e-410224c51c95	2024-10-23	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780 ndc (product): 65162-145
Cetirizine Hydrochloride	CETIRIZINE	Amneal Pharmaceuticals LLC	214936a2-adc4-422a-a8fe-4c3ce9e01f36	2024-07-31	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780 ndc (product): 65162-045
Cetirizine Hydrochloride	CETIRIZINE	Amneal Pharmaceuticals LLC	273172b2-9aaf-46fb-a1ce-2961650eacd3	2024-07-31	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780 ndc (product): 65162-046

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 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0129	Wal-Zyr	Cetirizine HCl	Walgreens	ANDA	Current
0536-4088	Cetirizine Hydrochloride	Cetirizine hydrochloride	Rugby Laboratories, Inc.	ANDA	Current
33992-0129	All Day Allergy Relief	Cetirizine HCl	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
41520-129	All Day Allergy	Cetirizine HCl	Care One (American Sales Company)	ANDA	Current
49348-984	All Day Allergy Relief	Cetirizine HCl	McKesson (Sunmark)	ANDA	Current
49348-984	All Day Allergy Relief	Cetirizine HCl	Strategic Sourcing Services LLC	ANDA	Current
53187-129	All Day Allergy	Cetirizine HCl	LIVE BETTER (The Great Atlantic & Pacific Tea Company)	ANDA	Current
55315-129	Cetirizine HCL 10 mg All Day Allergy Relief	Cetirizine Hydrochloride	Freds Inc	ANDA	Current
55315-129	Cetirizine HCL 10 mg All Day Allergy Relief	Cetirizine Hydrochloride	Freds Inc	ANDA	Current
55910-129	Allergy Relief	Cetirizine HCl	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-129	Allergy Relief	Cetirizine HCl	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-129	Allergy Relief	Cetirizine HCl	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-129	Allergy Relief	Cetirizine HCl	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
59726-024	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
59726-129	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
59726-129	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
59726-129	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
59726-129	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
62011-0052	24-Hour All Day Allergy	Cetirizine HCl	McKesson	ANDA	Current
62011-0205	All Day Allergy	Cetirizine HCl	McKesson (Health Mart)	ANDA	Current
62011-0205	All Day Allergy	Cetirizine HCl	Strategic Sourcing Services LLC	ANDA	Current
62011-0552	All Day Allergy	Cetirizine HCl	Strategic Sourcing Services LLC	ANDA	Current
62011-0552	All Day Allergy	Cetirizine HCl	McKesson (Health Mart)	ANDA	Current
62011-0552	All Day Allergy	Cetirizine HCl	Strategic Sourcing Services LLC	ANDA	Current
65162-045	Cetirizine Hydrochloride	Cetirizine	Amneal Pharmaceuticals	ANDA	Current
65162-046	Cetirizine Hydrochloride	Cetirizine	Amneal Pharmaceuticals	ANDA	Current
65162-145	Cetirizine Hydrochloride	Cetirizine	Amneal Pharmaceuticals	ANDA	Current
65162-146	Cetirizine Hydrochloride	Cetirizine	Amneal Pharmaceuticals	ANDA	Current
66715-6850	24 Hour Allergy	Cetirizine hydrochloride	Lil' Drug Store Products, Inc	ANDA	Current
66715-6850	24 Hour Allergy	Cetirizine hydrochloride	Lil' Drug Store Products, Inc	ANDA	Current
70000-0148	Allergy Relief	Cetirizine HCl	Cardinal Health (Leader) 70000	ANDA	Current
70000-0148	Allergy Relief	Cetirizine HCl	Cardinal Health (Leader) 70000	ANDA	Current
70000-0148	Allergy Relief	Cetirizine HCl	Cardinal Health (Leader) 70000	ANDA	Current
70253-129	All Day Allergy Relief	Cetirizine HCl	OUR FAMILY (NASH FINCH COMPANY)	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9182	ORIG	2010-01-26