FDA.reportPublic FDA data

Application 075124

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL240MGNoNo
002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGNoNo
003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL180MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075124-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18
A075124-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18
A075124-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1884e616aacf4f…
2026-09-14 22:38:342026-08A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1884e616aacf4f…
2026-09-14 22:38:342026-08A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1884e616aacf4f…
2026-08-18 06:07:402026-07A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A075124-001AB21b00525d2431f…
2019-09-15 20:21 UTC2019-09A075124-003AB21b00525d2431f…
2019-07-19 19:46 UTC2019-07A075124-001AB21ea99ee380514…
2019-07-19 19:46 UTC2019-07A075124-002AB21ea99ee380514…
2019-07-19 19:46 UTC2019-07A075124-003AB21ea99ee380514…

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 3 of 6 · 109 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack58eeb8bc-91d0-4cf8-a0d7-be3548d921962025-11-11Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEEugia US LLCf8d962ab-6cd4-43a1-a8fa-fb6548ac2a082025-11-07Warnings, Adverse reactionsName fallback
brand name: DILTIAZEM HYDROCHLORIDE
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMedical Purchasing Solutions, LLC41d75325-d935-ba54-e063-6394a90aade22025-10-23Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack22e653e5-4122-4d7d-b9ad-0bdc1390fb402025-10-20Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEScieGen Pharmaceuticals, Inc.1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672025-10-16Warnings, Adverse reactionsName fallback
brand name: DILTIAZEM HYDROCHLORIDE
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEScieGen Pharmaceuticals, Inc196fc367-330e-4d15-b1d6-084ad3f97ae72025-10-15Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEOceanside Pharmaceuticals862d65cb-a732-4786-b569-bad2eaafddfd2025-10-13Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAccord Healthcare, Inc.70293a05-d314-43fa-a2b1-398cfb39edf82025-10-09Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc8809dc9-b99b-4d30-a7da-0bc21aa90f9c2025-10-02Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEProPharma Distribution3f2942d7-f4d0-2d77-e063-6294a90a74ad2025-09-18Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc1ef9e90-6ff0-4ee5-86a3-1efee9c367892025-09-16Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Inc.ac9aa10d-cd52-4ac9-a01d-e3cbf14d49132025-08-30Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacke6d9397c-f8a2-42d6-88ca-55060b1d073a2025-08-26Warnings, Adverse reactionsName fallback
brand name: diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack9041cc05-29d2-41ca-a368-e953bf3443b52025-08-25Warnings, Adverse reactionsName fallback
brand name: diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack0089fc7a-a7aa-4873-b699-39a1b21616ca2025-08-20Warnings, Adverse reactionsName fallback
brand name: diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECipla USA, Inc.bce61158-201d-458c-be0c-9bdd2d3a0bec2025-08-01Warnings, Adverse reactionsName fallback
brand name: DILTIAZEM HYDROCHLORIDE
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEOCEANSIDE PHARMACEUTICALS43892b97-449d-45bc-bb09-29d47c655d652025-07-31Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMylan Institutional Inc.9942f1a2-f66d-4d9e-9794-49bee8abf5ab2025-07-18Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
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

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-5220Diltiazem Hydrochloridediltiazem hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5220Diltiazem Hydrochloridediltiazem hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5280Diltiazem Hydrochloridediltiazem hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5280Diltiazem Hydrochloridediltiazem hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5340Diltiazem Hydrochloridediltiazem hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5340Diltiazem Hydrochloridediltiazem hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
43063-619Diltiazem Hydrochloridediltiazem hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
51079-947Diltiazem Hydrochloridediltiazem hydrochlorideMylan Institutional Inc.ANDACurrent
55289-853Diltiazem Hydrochloridediltiazem hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39455ORIG1998-03-18
22419ORIG1998-03-18
8528ORIG1998-03-18