Application 077472

Type: ANDA
Sponsor: RANBAXY LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML	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
A077472-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2008-06-18

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	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2008-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077472-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	2008-06-18	`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 11 of 15 · 282 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	WALGREEN CO.	a9fd9b8f-509b-1ffa-e053-2a95a90a6d0f	2024-04-15	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	15eaa0d1-d18d-72b1-e063-6394a90a8a94	2024-04-12	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy, Inc.	e340cd4b-5413-42c6-a956-eb15c3807aeb	2024-03-29	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Camber Consumer Care Inc	941e4aa9-6388-424c-87ad-3ea2ec5aafea	2024-03-27	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	af7513ae-5107-477c-a7da-0ded9d53a55c	2024-03-27	Warnings	Name fallback brand name: cetirizine hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	e626bd59-dd18-465c-b740-9d04eb48c28e	2024-03-14	Adverse reactions	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride Tablets,10 mg	CETIRIZINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	d78223ba-80d5-47f8-e053-2a95a90aebdb	2024-03-06	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	d69083c4-b028-453c-8235-560b40ad358b	2024-03-01	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	6493d4f6-dead-45ec-ade1-28ce624af33d	2024-02-22	Warnings	Name fallback brand name: Cetirizine Hydrochloride generic name: CETIRIZINE HYDROCHLORIDE
Good Sense all day allergy	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	2f562a13-8909-4107-b135-10333707bab3	2024-01-24	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Good Sense all day allergy	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	c1a208c8-2554-4e8e-b506-aeb8e417d444	2024-01-24	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride Sugar Free Grape	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	016b66fd-dde9-4f13-afaf-a8aafbdeed1a	2024-01-23	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE 10 MG	CETIRIZINE HYDROCHLORIDE	SDA Laboratories, Inc.	222a7e77-33a6-44ca-9ab1-0bc4fc431aa3	2024-01-11	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	7d214cba-951d-464e-b37e-e83098944fe6	2024-01-11	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE 10 MG	CETIRIZINE HYDROCHLORIDE	TWIN MED, LLC	d9437d88-da59-5567-e053-2995a90a362b	2024-01-03	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE 10 MG	CETIRIZINE HYDROCHLORIDE	YYBA CORP	0502f197-21e1-44f2-b621-c8df1ccd956e	2024-01-03	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
All Day Allergy Relief	CETIRIZINE HYDROCHLORIDE	DOLGENCORP, INC.	0643ea78-9709-8526-e063-6394a90a227b	2023-12-15	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	a6492645-8438-4e82-aa31-7e5b4bccb220	2023-12-15	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Spirit Pharmaceutical LLC	c9eb5102-5514-4e69-8169-be7341e9fb66	2023-12-06	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Better Living Brands, LLC	f7deb8ca-4a26-aece-e053-6294a90aa685	2023-11-22	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31244	ORIG	2006-11-06