Application 206180

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 5MG BASE;12.5MG;160MGNoNo
002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 5MG BASE;25MG;160MGNoNo
003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 10MG BASE;12.5MG;160MGNoNo
004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 10MG BASE;25MG;160MGNoNo
005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 10MG BASE;25MG;320MGNoNo

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
A206180-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-19
A206180-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANEQ 5MG BASE;25MG;160MGTABLET / ORALAB2017-12-19
A206180-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-19
A206180-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANEQ 10MG BASE;25MG;160MGTABLET / ORALAB2017-12-19
A206180-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANEQ 10MG BASE;25MG;320MGTABLET / ORALAB2017-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206180-001AB
A206180-002AB
A206180-003AB
A206180-004AB
A206180-005AB

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 22:38:342026-08A206180-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-1984e616aacf4f…
2026-09-14 22:38:342026-08A206180-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2017-12-1984e616aacf4f…
2026-09-14 22:38:342026-08A206180-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-1984e616aacf4f…
2026-09-14 22:38:342026-08A206180-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2017-12-1984e616aacf4f…
2026-09-14 22:38:342026-08A206180-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2017-12-1984e616aacf4f…
2026-08-18 06:07:402026-07A206180-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07A206180-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2017-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07A206180-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07A206180-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2017-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07A206180-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2017-12-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206180-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206180-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2017-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206180-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206180-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2017-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206180-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2017-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206180-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206180-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2017-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206180-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206180-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2017-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206180-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2017-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206180-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206180-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2017-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206180-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206180-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2017-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206180-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2017-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206180-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206180-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2017-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206180-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206180-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2017-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206180-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2017-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206180-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206180-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2017-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206180-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206180-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2017-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206180-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2017-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206180-001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206180-002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;160MGTABLET / ORALAB2017-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206180-003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;160MGTABLET / ORALAB2017-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206180-004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;160MGTABLET / ORALAB2017-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206180-005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;320MGTABLET / ORALAB2017-12-1903ed91905a0d…

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 22:38:342026-08A206180-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206180-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A206180-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A206180-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A206180-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A206180-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206180-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206180-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206180-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206180-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206180-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206180-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206180-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206180-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206180-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206180-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206180-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206180-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206180-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206180-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206180-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206180-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206180-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206180-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206180-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206180-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206180-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206180-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206180-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206180-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206180-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206180-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206180-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206180-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206180-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206180-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206180-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206180-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206180-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206180-005AB103ed91905a0d…

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
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited6fba5243-ee00-4825-a04a-321cb6b49c562024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206180
application number: ANDA206180
ndc (product): 65862-834
ndc (product): 65862-838
ndc (product): 65862-835
ndc (product): 65862-837
ndc (product): 65862-836

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 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65862-834Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-834Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-834Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-834Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-834Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-835Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-835Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-835Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-835Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-835Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-836Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-836Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-836Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-836Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-836Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-837Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-837Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-837Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-837Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-837Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-838Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-838Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-838Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-838Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-838Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent