Application 203466

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDETABLET;ORAL16MG;12.5MGNoNo
002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDETABLET;ORAL32MG;12.5MGNoNo
003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDETABLET;ORAL32MG;25MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27
A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27
A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203466-001AB
A203466-002AB
A203466-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-2784e616aacf4f…
2026-09-14 22:38:342026-08A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-2784e616aacf4f…
2026-09-14 22:38:342026-08A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-2784e616aacf4f…
2026-08-18 06:07:402026-07A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203466-002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;12.5MGTABLET / ORALAB2017-11-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203466-003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE32MG;25MGTABLET / ORALAB2017-11-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203466-001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE16MG;12.5MGTABLET / ORALAB2017-11-27301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203466-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203466-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203466-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A203466-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203466-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203466-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203466-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203466-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203466-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203466-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203466-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203466-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203466-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203466-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203466-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203466-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203466-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203466-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203466-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203466-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203466-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203466-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203466-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203466-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203466-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203466-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203466-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203466-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203466-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203466-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203466-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203466-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203466-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203466-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203466-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203466-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203466-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203466-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203466-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203466-001AB1301d65b070ca…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
candesartan cilexetil and hydrochlorothiazideCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEZydus Lifesciences Limitedcb328bc1-5738-4620-b2b3-442e98388a862024-11-11Exact identifier
application applno (ANDA): 203466
application number: ANDA203466
ndc (product): 70771-1325
ndc (product): 70771-1327
ndc (product): 70771-1326

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-194candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-194candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-194candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-194candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-195candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-195candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-195candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-195candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-416candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-416candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-416candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-416candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1325candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1325candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1325candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1325candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1326candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1326candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1326candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1326candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1327candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1327candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1327candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1327candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent