Application 213557

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A213557-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2020-09-11

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy, Inc.	b45c95f2-91c9-55b5-e053-2995a90a75b7	2026-05-04	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557 ndc (product): 69842-234
Childrens Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy, Inc.	b955c7ed-29da-959f-e053-2a95a90a03d4	2026-05-04	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557 ndc (product): 69842-961
CHILDRENS CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	WALMART INC.	473ad691-2499-a706-e063-6394a90a9781	2026-01-30	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	WALGREEN CO.	9e728bf2-0cb9-ecf5-e053-2a95a90a408a	2026-01-08	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557 ndc (product): 0363-0471
Childrens Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	cd895177-3c25-4a1b-81a0-b85f4877787a	2025-10-14	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557 ndc (product): 58602-856
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	17e93c22-1ff7-4af9-bd5a-448836aec65f	2025-01-28	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557 ndc (product): 58602-838
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	f4ba3e0c-e6b3-2596-e053-2a95a90ab850	2024-06-11	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557
Childrens Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	WALGREEN CO.	a9fd9b8f-509b-1ffa-e053-2a95a90a6d0f	2024-04-15	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557 ndc (product): 0363-4025
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	KROGER COMPANY	b8b2af96-af48-5f63-e053-2995a90a7d7c	2021-05-06	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557 ndc (product): 30142-058
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	c111f6f3-e190-447f-b4a4-e277af641483	2021-05-06	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557 ndc (product): 58602-860
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	d9ebebb5-736a-4019-8c1a-030148de9d02	2021-05-06	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557 ndc (product): 58602-862

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0471	Cetirizine Hydrochloride	Cetirizine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-0471	Cetirizine Hydrochloride	Cetirizine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-0471	Cetirizine Hydrochloride	Cetirizine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-0471	Cetirizine Hydrochloride	Cetirizine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-4025	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-4025	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-4025	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	WALGREEN CO.	ANDA	Current
0363-4025	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	WALGREEN CO.	ANDA	Current
30142-058	Cetirizine Hydrochloride	Cetirizine Hydrochloride	KROGER COMPANY	ANDA	Current
30142-058	Cetirizine Hydrochloride	Cetirizine Hydrochloride	KROGER COMPANY	ANDA	Current
58602-838	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-838	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-856	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-856	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-860	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-860	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-862	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-862	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
69842-234	Cetirizine Hydrochloride	Cetirizine Hydrochloride	CVS Pharmacy, Inc.	ANDA	Current
69842-234	Cetirizine Hydrochloride	Cetirizine Hydrochloride	CVS Pharmacy, Inc.	ANDA	Current
69842-234	Cetirizine Hydrochloride	Cetirizine Hydrochloride	CVS Pharmacy, Inc.	ANDA	Current
69842-961	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	CVS Pharmacy, Inc.	ANDA	Current
69842-961	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	CVS Pharmacy, Inc.	ANDA	Current
69842-961	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	CVS Pharmacy, Inc.	ANDA	Current