Application 091022

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGNoNo
002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL180MGNoNo
003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL240MGNoNo
004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL300MGNoNo
005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL360MGNoNo
006DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL420MGNoNo

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
A091022-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28
A091022-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28
A091022-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28
A091022-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28
A091022-005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28
A091022-006DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A091022-001AB4
A091022-002AB4
A091022-003AB4
A091022-004AB4
A091022-005AB4
A091022-006AB4

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 22:38:342026-08A091022-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-2884e616aacf4f…
2026-09-14 22:38:342026-08A091022-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-2884e616aacf4f…
2026-09-14 22:38:342026-08A091022-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-2884e616aacf4f…
2026-09-14 22:38:342026-08A091022-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-2884e616aacf4f…
2026-09-14 22:38:342026-08A091022-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-2884e616aacf4f…
2026-09-14 22:38:342026-08A091022-006DILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-2884e616aacf4f…
2026-08-18 06:07:402026-07A091022-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A091022-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A091022-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A091022-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A091022-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A091022-006DILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091022-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091022-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091022-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091022-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091022-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091022-006DILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091022-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091022-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091022-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091022-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091022-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091022-006DILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091022-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091022-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091022-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091022-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091022-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091022-006DILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091022-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091022-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091022-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091022-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091022-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091022-006DILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091022-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091022-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091022-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091022-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42012-09-28b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A091022-001AB4184e616aacf4f…
2026-09-14 22:38:342026-08A091022-002AB4184e616aacf4f…
2026-09-14 22:38:342026-08A091022-003AB4184e616aacf4f…
2026-09-14 22:38:342026-08A091022-004AB4184e616aacf4f…
2026-09-14 22:38:342026-08A091022-005AB4184e616aacf4f…
2026-09-14 22:38:342026-08A091022-006AB4184e616aacf4f…
2026-08-18 06:07:402026-07A091022-001AB41caaa826d4ba7…
2026-08-18 06:07:402026-07A091022-002AB41caaa826d4ba7…
2026-08-18 06:07:402026-07A091022-003AB41caaa826d4ba7…
2026-08-18 06:07:402026-07A091022-004AB41caaa826d4ba7…
2026-08-18 06:07:402026-07A091022-005AB41caaa826d4ba7…
2026-08-18 06:07:402026-07A091022-006AB41caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091022-001AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091022-002AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091022-003AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091022-004AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091022-005AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091022-006AB41011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091022-001AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091022-002AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091022-003AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091022-004AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091022-005AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091022-006AB4131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091022-001AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091022-002AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091022-003AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091022-004AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091022-005AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091022-006AB416a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091022-001AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091022-002AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091022-003AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091022-004AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091022-005AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091022-006AB41fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091022-001AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091022-002AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091022-003AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091022-004AB41b8a1b40f171c…

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 4 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEIngenus Pharmaceuticals, LLC355f560a-8ebb-4661-ad74-2a22f707d7f82025-06-17Warnings, Adverse reactionsName fallback
brand name: diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
TIADYLT ERDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackb4b4e53e-fc99-4f34-abc2-57e4f28aff842025-06-13Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc044f774-783f-4920-a8a1-6d4b1b3820c12025-06-11Warnings, Adverse reactionsName fallback
brand name: diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Cartia XTDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackde671934-25a8-4df6-b7a1-97e0337e9e2b2025-06-02Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDETeva Pharmaceuticals USA, Inc.69ca7cae-fdf3-413a-900b-95cf6e9e7b632025-05-30Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDESun Pharmaceutical Industries, Inc.976d9dd0-4f11-4439-b84e-0c0f0e018d8b2025-05-22Warnings, Adverse reactionsName fallback
brand name: Diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEViona Pharmaceuticals Inc43cffe12-304a-4e15-9512-94f812188f1a2025-05-05Warnings, Adverse reactionsName fallback
brand name: Diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
TIADYLT ERDILTIAZEM HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.1278cd76-b8e9-42d9-ad19-6858e72cf9f22025-05-02Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
TIADYLT ERDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limitedd88e3546-3984-4dc9-893a-a29e958045502025-05-02Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECoupler LLC3418eb02-117e-a71a-e063-6394a90a826e2025-05-01Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.1e2f2025-0350-40c4-ab42-3b57f3d105a62025-05-01Warnings, Adverse reactionsName fallback
brand name: diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEActavis Pharma, Inc.178eec1f-1d4d-4a38-b66a-d3ba3de06c3d2025-05-01Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limitedfe790439-85d4-4cd8-a385-149ea3442a382025-05-01Warnings, Adverse reactionsName fallback
brand name: diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
CardizemDILTIAZEM HYDROCHLORIDEBausch Health US LLCf3e7ecef-f360-4987-a4f5-933214130ab22025-04-30Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEIngenus Pharmaceuticals, LLC64401d2a-bd5b-43fd-879a-e9d16345e8272025-04-17Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEAvKARE31e63a95-9e62-01c8-e063-6294a90af0e12025-04-03Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETSOceanside Pharmaceuticals73b3607a-99d0-44d8-92ef-0074684c9d7d2025-04-01Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
Cartia XTDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacke02f5fad-6482-4d5d-91c5-0ae6b0ce15b82025-03-06Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECoupler LLC2ced821f-19a6-4c7e-e063-6394a90adb802025-01-30Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECoupler LLC2cd92b83-075e-b069-e063-6294a90a9fff2025-01-29Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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