Application 077179

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 2.5MG BASE;10MGNoNo
002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 5MG BASE;10MGNoNo
003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 5MG BASE;20MGNoNo
004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 10MG BASE;20MGNoNo
005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 5MG BASE;40MGNoNo
006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 10MG BASE;40MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077179-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORAL2007-05-18
A077179-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORAL2007-05-18
A077179-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORAL2007-05-18
A077179-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORAL2007-05-18
A077179-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORAL2011-07-05
A077179-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORAL2011-07-05

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 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077179-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORAL2007-05-1884e616aacf4f…
2026-09-14 22:38:342026-08A077179-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORAL2007-05-1884e616aacf4f…
2026-09-14 22:38:342026-08A077179-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORAL2007-05-1884e616aacf4f…
2026-09-14 22:38:342026-08A077179-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORAL2007-05-1884e616aacf4f…
2026-09-14 22:38:342026-08A077179-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORAL2011-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A077179-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORAL2011-07-0584e616aacf4f…
2026-08-18 06:07:402026-07A077179-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORAL2007-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077179-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORAL2007-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077179-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORAL2007-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077179-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORAL2007-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077179-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORAL2011-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077179-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORAL2011-07-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077179-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORAL2007-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077179-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORAL2007-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077179-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORAL2007-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077179-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORAL2007-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077179-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORAL2011-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077179-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORAL2011-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077179-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORAL2007-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077179-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORAL2007-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077179-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORAL2007-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077179-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORAL2007-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077179-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORAL2011-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077179-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORAL2011-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077179-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORAL2007-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077179-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORAL2007-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077179-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORAL2007-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077179-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORAL2007-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077179-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORAL2011-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077179-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORAL2011-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077179-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORAL2007-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077179-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORAL2007-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077179-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORAL2007-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077179-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORAL2007-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077179-005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;40MGCAPSULE / ORAL2011-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077179-006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;40MGCAPSULE / ORAL2011-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077179-001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 2.5MG BASE;10MGCAPSULE / ORAL2007-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077179-002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;10MGCAPSULE / ORAL2007-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077179-003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 5MG BASE;20MGCAPSULE / ORAL2007-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077179-004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEEQ 10MG BASE;20MGCAPSULE / ORAL2007-05-18b8a1b40f171c…

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDELupin Pharmaceuticals, Inc.968c611b-43a7-40f0-9ed3-aa67ee88364b2025-10-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackd058e426-8786-4fd3-a771-992e4558c1352025-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.7c75fa72-9b0f-44bf-a745-dfa647ed1e782025-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBluePoint Laboratoriesdf8e23c8-6c8f-4293-8a37-5ad3d48dba942023-05-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDr.Reddy's Laboratories Limitedf12f18bb-7ddb-e7dc-4edd-32f4ac212bca2022-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDr.Reddy's Laboratories Limitedca014f06-982c-6fe1-9948-a3701dd35d342022-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amlodipine Besylate and Benazepril Hydrochloride

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 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7370Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7370Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7370Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7371Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7371Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7371Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7372Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7372Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7372Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7373Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7373Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7373Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7670Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7670Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7670Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7671Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7671Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7671Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
43063-402Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-5366Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7644Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7645Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7645Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7645Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7746Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7746Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7746Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
68071-1878Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4130Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4130Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
71335-0803Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
71335-0803Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
71335-1383Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
71335-1383Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9016ORIG2007-05-29