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 5 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc7c6a74e-5f73-4265-a0e0-8fd2cd26909e2025-01-21Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Limitedd9c5c1ed-1a9d-494c-b798-9da09ba1fe1b2024-12-26Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Limited61b9ca82-7d41-4f49-b4a0-549c9473c4472024-10-30Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions88b150a6-4c8d-49c8-88df-f3606c3354722024-10-28Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs70f167a1-ec7f-4969-b446-166af3e52c052024-09-13Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs74620be9-5120-491a-a171-e50612c065412024-09-13Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEDr. Reddy's Labratories Inc.f1d09c53-5eb9-0b7c-e977-e2a602e84e5f2024-08-19Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENuCare Pharmaceuticals,Inc.54b0b11d-adc0-4afb-e054-00144ff88e882024-07-17Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEChartwell RX, LLC51abce7b-e3d1-44b5-bccc-d463150d0bba2024-06-19Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENuCare Pharmaceuticals,Inc.7cdb473a-e6d5-48e8-e053-2a91aa0aaeb72024-06-12Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENuCare Pharmaceuticals,Inc.636556f6-2987-984f-e053-2991aa0a201a2024-06-06Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackfe7ca564-16b8-4c54-aa09-3e2ed0c2596a2024-05-17Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutionsf317de31-495c-4268-8171-89534bf1dd362024-05-07Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHikma Pharmaceuticals USA Inc.453b73bd-c52d-4d72-a0b3-47588e723e0b2024-04-09Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackde2a0c48-7fc4-4760-b465-a79299876e6e2024-04-05Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack74232d69-1a8c-449d-8e8e-85488e6cc8f82024-04-03Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack6ca6a648-fc67-4cf8-a1f7-787c9574e3a12024-03-27Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack0e9b4421-bc43-4a77-b49b-e3f53d1e0f012024-01-10Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacka6cc3b99-2c0f-4d8a-8393-ec042ed7c8922024-01-10Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a62024-01-10Warnings, 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