Application 077829

Type: ANDA
Sponsor: UNIQUE PHARM LABS

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	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	Yes
003	CETIRIZINE HYDROCHLORIDE HIVES	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	RLD / RS	Approval date
A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2009-08-26
A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RS	2009-08-26
A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2009-08-26
A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2009-08-26

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`ea99ee380514…`

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GOOD REMEDIES All Day Allergy Relief	CETIRIZINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	44410d76-5940-4611-be45-579e2db8a65d	2026-08-24	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4913192a-7364-3f19-e054-00144ff8d46c	2026-08-20	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829 ndc (product): 68071-1964
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	f2f42f36-6b09-4140-e053-2a95a90af813	2026-06-29	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Goodmeds All Day Allergy Relief Cetirizine HCl	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	cd13a70e-b9e2-41be-97ea-f022442b6460	2026-04-08	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	Pioneer Life Sciences, LLC	5249b83c-30d4-4b5b-aeb1-f52418ba079f	2026-04-06	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Indoor and Outdoor Allergy Relief	CETIRIZINE HCL	Famora Inc.	2a94d25c-aacf-4f5c-b406-815f0e1d0611	2026-03-18	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sportpharm LLC	dd50d2e9-3de7-4c44-96ed-39ef04dae702	2026-02-06	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Strategic Sourcing Services LLC	54509525-ad99-4165-a571-47ece058e292	2026-01-29	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Prodose, Inc	e0e5f482-0282-410c-8c40-0a33ca4ea23a	2026-01-26	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829 ndc (product): 68210-4159
Allergy Relief	CETIRIZINE HCL	Pioneer Life Sciences, LLC	205b42e0-9d02-4755-9ee6-5883147abeb3	2025-12-23	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	Pioneer Life Sciences, LLC	b275feae-56a1-4a60-a564-8d7b18c06aa2	2025-12-23	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	NUVICARE LLC	c728edf3-e6b5-4860-b966-39cf3ee4ff77	2025-12-19	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
RIGHT REMEDIES ALL-DAY Allergy Relief	CETIRIZINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	8227edbe-88d5-4d79-9175-891dd9566357	2025-11-20	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	5481ccb3-b311-4b25-b923-4fe8522ea92b	2025-11-05	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829 ndc (product): 16571-402
ValuMeds All Day Allergy Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	3071238a-6b35-4da8-8305-eced56c513ce	2025-10-23	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
CVS Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy	3d711302-dc4e-0a69-e063-6394a90ade10	2025-09-18	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cabinet Allergy Relief Refill Cetirizine HCI	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	0eaf9d27-e221-4cdd-97bc-478c775e3d67	2025-07-03	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	NUVICARE LLC	09dfdce2-7184-4247-983c-a5667e4a9da1	2025-06-09	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
ALLERGY RELIEF	CETIRIZINE HCL	Pioneer Life Sciences, LLC	110adf3c-84ce-48a1-8a22-89ee3eec22d9	2025-06-01	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cabinet All Day Allergy Relief	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	889316bc-5f98-426a-9750-2fdb0c427408	2025-04-07	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829

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 2 · 86 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0179-8301	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Kaiser Foundation Hospitals	ANDA	Current
0179-8302	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Kaiser Foundation Hospitals	ANDA	Current
10544-670	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
16571-401	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-401	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Rising Pharma Holdings, Inc.	ANDA	Current
16571-402	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Rising Pharma Holdings, Inc.	ANDA	Current
16571-402	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
33261-393	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
35356-864	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-864	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-864	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
46994-658	Allergy Relief	Cetirizine Hydrochloride	SAVE-A-LOT FOOD STORES, LTD.	ANDA	Current
46994-658	Allergy Relief	Cetirizine Hydrochloride	SAVE-A-LOT FOOD STORES, LTD.	ANDA	Current
50090-1089	Cetirizine Hydrochloride	Cetirizine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1089	Cetirizine Hydrochloride	Cetirizine Hydrochloride	A-S Medication Solutions	ANDA	Current
53002-1259	Cetirizine Hydrochloride	Cetirizine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1259	Cetirizine Hydrochloride	Cetirizine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-331	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-331	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-429	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-429	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-429	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-538	Cetirizine Hydrochloride	Cetirizine Hydrochloride	DIRECT RX	ANDA	Current
61919-538	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-538	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-538	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-538	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
63629-4914	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-4914	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-4914	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8041	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8041	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
67296-1085	Cetirizine Hydrochloride	Cetirizine Hydrochloride	RedPharm Drug	ANDA	Current
67296-1085	Cetirizine Hydrochloride	Cetirizine Hydrochloride	RedPharm Drug	ANDA	Current
67668-161	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Unique Pharmaceutical Laboratories	ANDA	Current
67668-162	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Unique Pharmaceutical Laboratories	ANDA	Current
68071-1964	Cetirizine Hydrochloride	Cetirizine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1964	Cetirizine Hydrochloride	Cetirizine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68210-0450	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-1190	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-1190	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-4112	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-4112	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-4112	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-4136	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-4136	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-4136	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-4159	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-4159	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68210-4159	Allergy Relief	Cetirizine Hydrochloride	Spirit Pharmaceutical LLC	ANDA	Current
68788-0790	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-0790	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-0790	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-0790	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-0790	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0182	Cetirizine Hydrochloride	Cetirizine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0182	Cetirizine Hydrochloride	Cetirizine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0182	Cetirizine Hydrochloride	Cetirizine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0182	Cetirizine Hydrochloride	Cetirizine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0182	Cetirizine Hydrochloride	Cetirizine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0182	Cetirizine Hydrochloride	Cetirizine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0182	Cetirizine Hydrochloride	Cetirizine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0182	Cetirizine Hydrochloride	Cetirizine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-199	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-199	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-199	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70985-001	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Drug Ocean LLC	ANDA	Current
70985-001	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Drug Ocean LLC	ANDA	Current
70985-001	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Drug Ocean LLC	ANDA	Current
70985-001	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Drug Ocean LLC	ANDA	Current
70985-002	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Drug Ocean LLC	ANDA	Current
70985-002	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Drug Ocean LLC	ANDA	Current
70985-002	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Drug Ocean LLC	ANDA	Current
70985-002	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Drug Ocean LLC	ANDA	Current
71205-093	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-093	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-164	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-164	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0300	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0300	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current