Application 076677

Type: ANDA
Sponsor: MYLAN

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
003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	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
A076677-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A076677-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27
A076677-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27
A076677-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	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 5 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
2022-10-28 04:53 UTC	2022-10	A076677-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076677-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076677-003	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076677-004	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076677-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076677-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076677-003	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076677-004	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076677-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076677-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076677-003	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076677-004	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076677-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076677-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076677-003	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076677-004	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Cardinal Health 107, LLC	0b0190c7-acfd-4140-bcaf-9fe835ebaf49	2026-07-30	Warnings	Exact identifier application applno (ANDA): 076677 application number: ANDA076677 ndc (product): 55154-5399
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Safecor Health, LLC	734118ec-bf9a-4e58-b728-50b6c832b270	2026-05-01	Warnings	Exact identifier application applno (ANDA): 076677 application number: ANDA076677
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Mylan Institutional Inc.	bd0dc7f6-5fb9-4381-bd81-b150b75a2c68	2025-07-18	Warnings	Exact identifier application applno (ANDA): 076677 application number: ANDA076677 ndc (product): 51079-597
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	487ae0f0-320c-4534-b9e2-0e215f167cea	2022-01-12	Warnings	Exact identifier application applno (ANDA): 076677 application number: ANDA076677 ndc (product): 0378-3635 ndc (product): 0378-3637

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3635	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3635	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3635	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3635	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3637	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3637	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3637	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3637	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
12634-987	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Apotheca Inc.	ANDA	Current
51079-597	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-597	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-597	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Institutional Inc.	ANDA	Current
55154-5399	Cetirizine Hydrochloride	cetirizine hydrochloride	Cardinal Health	ANDA	Current
55154-5399	Cetirizine Hydrochloride	cetirizine hydrochloride	Cardinal Health	ANDA	Current
55154-5399	Cetirizine Hydrochloride	cetirizine hydrochloride	Cardinal Health	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8946	ORIG	2008-01-09
18450	ORIG	2008-01-08