Application 078450

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDETABLET;ORAL12.5MG;EQ 10MG BASENoNo
002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDETABLET;ORAL12.5MG;EQ 20MG BASENoNo
003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDETABLET;ORAL25MG;EQ 20MG BASENoNo

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
A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-24
A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-24
A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078450-001AB
A078450-002AB
A078450-003AB

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 22:38:342026-08A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-2484e616aacf4f…
2026-09-14 22:38:342026-08A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-2484e616aacf4f…
2026-09-14 22:38:342026-08A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-2484e616aacf4f…
2026-08-18 06:07:402026-07A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078450-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORALAB2007-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078450-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORALABRS2007-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078450-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORALAB2007-08-24301d65b070ca…

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 22:38:342026-08A078450-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078450-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078450-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078450-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078450-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078450-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078450-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078450-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078450-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078450-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078450-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078450-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078450-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078450-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078450-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078450-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078450-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078450-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078450-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078450-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078450-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078450-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078450-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078450-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078450-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078450-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078450-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078450-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078450-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078450-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078450-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078450-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078450-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078450-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078450-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078450-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078450-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078450-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078450-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078450-001AB1301d65b070ca…

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
QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma Limited50a58159-9572-4445-9859-b392632597da2024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078450
application number: ANDA078450
ndc (product): 65862-162
ndc (product): 65862-163
ndc (product): 65862-161

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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35356-998Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
65862-161QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-161Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-161Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-161QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-161QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-161QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-161QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-162QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-162Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-162Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-162QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-162QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-162QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-162QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-163QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-163Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-163Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-163QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-163QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-163QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-163QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23907ORIG2007-09-24