FDA.reportPublic FDA data

Valsartan and Hydrochlorothiazide

Product NDC
63629-8142
11-digit product format
636298142
Labeler code
63629
Product ID
63629-8142_df904e2b-8858-43a6-b570-96ed5645fbb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203145
Marketing category
ANDA
Marketing start
2013-04-19
Marketing end
0000-00-00
Substance
VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength
160 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-8142DDiscontinued by firm2026-10-02
excluded packagepackage63629-814263629-8142-1DDiscontinued by firm2026-10-02

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-8142-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-8142-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-8142-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-8142-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-8142-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-8142-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-8142-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-8142-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-8142-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-8142-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-8142-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-8142-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63629-8142-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63629-8142-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-8142-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductYUnknown FDA exclusion code: Ye2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-8142-1YUnknown FDA exclusion code: Ye2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductYUnknown FDA exclusion code: Y9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-8142-1YUnknown FDA exclusion code: Y9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductYUnknown FDA exclusion code: Y110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-8142-1YUnknown FDA exclusion code: Y110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;80MGTABLET / ORALAB2013-04-19
A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;160MGTABLET / ORALAB2013-04-19
A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;320MGTABLET / ORALAB2013-04-19
A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;160MGTABLET / ORALAB2013-04-19
A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;320MGTABLET / ORALAB2013-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A203145-001AB
A203145-002AB
A203145-003AB
A203145-004AB
A203145-005AB

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-1984e616aacf4f…
2026-09-14 22:38:342026-08A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-1984e616aacf4f…
2026-09-14 22:38:342026-08A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-1984e616aacf4f…
2026-09-14 22:38:342026-08A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-1984e616aacf4f…
2026-09-14 22:38:342026-08A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-1984e616aacf4f…
2026-08-18 06:07:402026-07A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-1903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203145-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203145-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203145-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A203145-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A203145-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A203145-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203145-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203145-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-005AB103ed91905a0d…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-8142-12022-05-09C16284748780-1ba0f9c33-1d21-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use valsartan and hydrochlorothiazide tablets, safely and effectively. See full prescribing information for valsartan and hydrochlorothiazide tablets. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack167f49f0-2d39-49a2-9f9e-1359a7c7ba3d2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC191d5710-7b8a-0b61-e063-6394a90afd412026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCdb118092-2002-7a55-e053-2a95a90a7b2c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCdb4d84ce-cf51-61dc-e053-2a95a90a2cfd2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsddc8b9e7-ceb1-4b6c-aa98-1c2cb98b0fc82024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions7b3fbdc9-d7e0-498f-a52d-e8a6b34f4a1f2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack497223a9-0d53-4f79-b031-07cc5204d80f2023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions89ce2fb1-330c-45f9-bd37-b402feea93782023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsef100fa1-dd63-4287-8543-480a82ace1682023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited771afba6-8769-4ea8-afec-358dba0aaefe2022-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPa9098fc6-3d2a-404f-a4cd-2e181ebbd6262022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPe0349fe8-90a4-4236-9686-f0c9c00a001c2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145