Application 075401

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAZTIA XTDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGNoNo
002TAZTIA XTDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL180MGNoNo
003TAZTIA XTDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL240MGNoNo
004TAZTIA XTDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL300MGNoNo
005TAZTIA XTDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL360MGNoNo

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
A075401-001TAZTIA XTDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10
A075401-002TAZTIA XTDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10
A075401-003TAZTIA XTDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10
A075401-004TAZTIA XTDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10
A075401-005TAZTIA XTDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10

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 22:38:342026-08A075401-001TAZTIA XT120MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1084e616aacf4f…
2026-09-14 22:38:342026-08A075401-002TAZTIA XT180MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1084e616aacf4f…
2026-09-14 22:38:342026-08A075401-003TAZTIA XT240MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1084e616aacf4f…
2026-09-14 22:38:342026-08A075401-004TAZTIA XT300MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1084e616aacf4f…
2026-09-14 22:38:342026-08A075401-005TAZTIA XT360MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1084e616aacf4f…
2026-08-18 06:07:402026-07A075401-001TAZTIA XT120MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10caaa826d4ba7…
2026-08-18 06:07:402026-07A075401-002TAZTIA XT180MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10caaa826d4ba7…
2026-08-18 06:07:402026-07A075401-003TAZTIA XT240MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10caaa826d4ba7…
2026-08-18 06:07:402026-07A075401-004TAZTIA XT300MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10caaa826d4ba7…
2026-08-18 06:07:402026-07A075401-005TAZTIA XT360MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075401-001TAZTIA XT120MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075401-002TAZTIA XT180MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075401-003TAZTIA XT240MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075401-004TAZTIA XT300MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075401-005TAZTIA XT360MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075401-001TAZTIA XT120MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075401-002TAZTIA XT180MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075401-003TAZTIA XT240MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075401-004TAZTIA XT300MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075401-005TAZTIA XT360MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075401-001TAZTIA XT120MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075401-002TAZTIA XT180MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075401-003TAZTIA XT240MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075401-004TAZTIA XT300MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075401-005TAZTIA XT360MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075401-001TAZTIA XT120MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075401-002TAZTIA XT180MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075401-003TAZTIA XT240MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075401-004TAZTIA XT300MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075401-005TAZTIA XT360MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075401-001TAZTIA XT120MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075401-002TAZTIA XT180MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075401-003TAZTIA XT240MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075401-004TAZTIA XT300MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075401-005TAZTIA XT360MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075401-001TAZTIA XT120MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075401-002TAZTIA XT180MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075401-003TAZTIA XT240MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075401-004TAZTIA XT300MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075401-005TAZTIA XT360MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-1003ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 145 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075401-001AB41301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075401-002AB41301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075401-003AB41301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075401-004AB41301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075401-005AB41301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075401-001AB411e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075401-002AB411e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075401-003AB411e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075401-004AB411e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075401-005AB411e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075401-001AB418072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075401-002AB418072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075401-003AB418072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075401-004AB418072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075401-005AB418072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075401-001AB415c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075401-002AB415c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075401-003AB415c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075401-004AB415c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075401-005AB415c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075401-001AB415d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075401-002AB415d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075401-003AB415d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075401-004AB415d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075401-005AB415d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075401-001AB414b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075401-002AB414b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075401-003AB414b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075401-004AB414b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075401-005AB414b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075401-001AB4174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075401-002AB4174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075401-003AB4174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075401-004AB4174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075401-005AB4174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075401-001AB41bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075401-002AB41bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075401-003AB41bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075401-004AB41bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075401-005AB41bb7c543d1eb4…

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 · 110 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
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
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
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDESun Pharmaceutical Industries, Inc.976d9dd0-4f11-4439-b84e-0c0f0e018d8b2025-05-22Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEViona Pharmaceuticals Inc43cffe12-304a-4e15-9512-94f812188f1a2025-05-05Warnings, Adverse reactionsName fallback
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
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.1e2f2025-0350-40c4-ab42-3b57f3d105a62025-05-01Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEActavis Pharma, Inc.178eec1f-1d4d-4a38-b66a-d3ba3de06c3d2025-05-01Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limitedfe790439-85d4-4cd8-a385-149ea3442a382025-05-01Warnings, Adverse reactionsName fallback
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
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEAvKARE31e63a95-9e62-01c8-e063-6294a90af0e12025-04-03Warnings, Adverse reactionsName fallback
generic 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
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECoupler LLC2cd92b83-075e-b069-e063-6294a90a9fff2025-01-29Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
CARTIA XTDILTIAZEM HYDROCHLORIDEDirectRxdbfda3a5-5602-6e47-e053-2995a90ac07b2025-01-22Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM 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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24658-341Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-342Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-343Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-344Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-345Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
62037-696TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-696TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-696TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-697TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-697TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-697TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-698TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-698TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-698TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-699TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-699TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-699TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-700TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-700TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-700TAZTIADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22468ORIG2005-07-22
8648ORIG2004-06-18