Application 077686

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077686-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15
A077686-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15
A077686-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15
A077686-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15
A077686-005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15
A077686-006DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077686-001AB
A077686-002AB
A077686-003AB
A077686-004AB
A077686-005AB
A077686-006AB

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 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077686-001DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15c2088c7a36db…
2026-10-15 13:18:302026-09A077686-002DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15c2088c7a36db…
2026-10-15 13:18:302026-09A077686-003DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15c2088c7a36db…
2026-10-15 13:18:302026-09A077686-004DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15c2088c7a36db…
2026-10-15 13:18:302026-09A077686-005DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15c2088c7a36db…
2026-10-15 13:18:302026-09A077686-006DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15c2088c7a36db…
2026-09-14 22:38:342026-08A077686-001DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2010-03-1584e616aacf4f…
2026-09-14 22:38:342026-08A077686-002DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2010-03-1584e616aacf4f…
2026-09-14 22:38:342026-08A077686-003DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2010-03-1584e616aacf4f…
2026-09-14 22:38:342026-08A077686-004DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2010-03-1584e616aacf4f…
2026-09-14 22:38:342026-08A077686-005DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2010-03-1584e616aacf4f…
2026-09-14 22:38:342026-08A077686-006DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2010-03-1584e616aacf4f…
2026-08-18 06:07:402026-07A077686-001DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15caaa826d4ba7…
2026-08-18 06:07:402026-07A077686-002DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15caaa826d4ba7…
2026-08-18 06:07:402026-07A077686-003DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15caaa826d4ba7…
2026-08-18 06:07:402026-07A077686-004DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15caaa826d4ba7…
2026-08-18 06:07:402026-07A077686-005DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15caaa826d4ba7…
2026-08-18 06:07:402026-07A077686-006DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077686-001DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077686-002DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077686-003DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077686-004DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077686-005DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077686-006DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077686-001DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2010-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077686-002DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2010-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077686-003DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2010-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077686-004DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2010-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077686-005DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2010-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077686-006DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2010-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077686-001DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2010-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077686-002DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2010-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077686-003DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2010-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077686-004DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2010-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077686-005DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2010-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077686-006DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2010-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077686-001DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077686-002DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077686-003DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077686-004DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2010-03-15fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A077686-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077686-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077686-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077686-004AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077686-005AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077686-006AB1c2088c7a36db…
2026-09-14 22:38:342026-08A077686-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077686-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077686-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077686-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A077686-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A077686-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A077686-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077686-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077686-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077686-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077686-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077686-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077686-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077686-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077686-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077686-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077686-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077686-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077686-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077686-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077686-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077686-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077686-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077686-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077686-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077686-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077686-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077686-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077686-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077686-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077686-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077686-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077686-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077686-004AB1fd3edfee7708…

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 · 109 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Limitedd9c5c1ed-1a9d-494c-b798-9da09ba1fe1b2024-12-26Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Limited61b9ca82-7d41-4f49-b4a0-549c9473c4472024-10-30Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions88b150a6-4c8d-49c8-88df-f3606c3354722024-10-28Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs70f167a1-ec7f-4969-b446-166af3e52c052024-09-13Warnings, Adverse reactionsName fallback
brand name: diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs74620be9-5120-491a-a171-e50612c065412024-09-13Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
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
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEChartwell RX, LLC51abce7b-e3d1-44b5-bccc-d463150d0bba2024-06-19Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENuCare Pharmaceuticals,Inc.7cdb473a-e6d5-48e8-e053-2a91aa0aaeb72024-06-12Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENuCare Pharmaceuticals,Inc.636556f6-2987-984f-e053-2991aa0a201a2024-06-06Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
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
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHikma Pharmaceuticals USA Inc.453b73bd-c52d-4d72-a0b3-47588e723e0b2024-04-09Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
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
brand name: Diltiazem Hydrochloride
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
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack762c3007-b22f-4d35-87b4-191fec8b3a9a2023-11-20Warnings, 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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52544-691Matzim LADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
52544-691Matzim LADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
52544-692Matzim LADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
52544-692Matzim LADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
52544-693Matzim LADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
52544-693Matzim LADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
52544-694Matzim LADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
52544-694Matzim LADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
52544-695Matzim LADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
52544-695Matzim LADiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
70518-1950Matzim LADiltiazem HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2270Matzim LADiltiazem HydrochlorideREMEDYREPACK INC.ANDACurrent