FDA.reportPublic FDA data

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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075401-001TAZTIA XT120MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10a50c72e98297…
2026-08-01 22:54:322026-06A075401-002TAZTIA XT180MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10a50c72e98297…
2026-08-01 22:54:322026-06A075401-003TAZTIA XT240MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10a50c72e98297…
2026-08-01 22:54:322026-06A075401-004TAZTIA XT300MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10a50c72e98297…
2026-08-01 22:54:322026-06A075401-005TAZTIA XT360MGCAPSULE, EXTENDED RELEASE / ORAL2003-04-10a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackec928ee5-0809-4ba5-82ca-ecfed99ebb5a2026-07-21Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMajor Pharmaceuticalse7476adc-a940-4e76-a1dd-c418de493bc02026-07-14Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackfb6a6199-bb70-476e-a2a2-b7594c9c001a2026-07-10Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEAmerican Health Packaging11b43a17-8038-462b-8902-259431ad52562026-06-22Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions465dbab3-f201-4441-8f55-92a843b5134f2026-06-19Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEGolden State Medical Supply, Inc.c9f17187-e958-106b-e053-2a95a90a54d82026-06-16Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack50df9f09-aa2f-495d-a25c-7c5c0fdffcf02026-05-27Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHospira, Inc.bba03666-ff4f-4bf6-fa92-78e1ec2d90732026-05-24Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack76e04232-b3da-48e8-a944-5f4f97a508df2026-05-13Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEUpsher-Smith Laboratories, LLCf276d9fe-a685-4d99-ad82-d4452ef4ba982026-05-08Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENorthstar Rx LLCe2511ffe-5821-4f64-a469-f8ef9618b1b52026-05-05Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limited8329d0ac-d68c-48d2-9cbc-e1a1b60192d92026-05-01Name fallback
generic name: DILTIAZEM HYDROCHLORIDE
Cartia XTDILTIAZEM HYDROCHLORIDEActavis Pharma, Inc.2dc2b889-8443-4f7f-83be-86c68e1798042026-04-30Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Inc.04a85be5-f746-418e-8e37-292703f169342026-04-29Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECardinal Health 107, LLCbdb9e7cf-bfbb-48b4-a8be-9038820d82792026-04-23Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEREMEDYREPACK INC.5e935265-d0fc-4223-835f-72426eeea6c42026-04-10Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEPreferred Pharmaceuticals Inc.3d594530-885f-45c7-b8a5-fd7e503ff83f2026-04-06Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEUpsher-Smith Laboratories, LLCbb32d681-9a83-431e-9984-a5cee2c948522026-04-01Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESlate Run Pharmaceuticals, LLCf7137458-0db3-7ecd-e053-6394a90a5f952026-03-27Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions839af3af-4040-4cf4-8d4a-881a053514cc2026-03-17Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE

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