Application 075116

Type
ANDA
Sponsor
VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGNoNo
002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL180MGNoNo
003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL240MGNoNo
004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL300MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075116-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23
A075116-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23
A075116-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23
A075116-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A075116-001AB3
A075116-002AB3
A075116-003AB3
A075116-004AB3

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075116-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075116-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075116-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075116-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075116-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075116-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075116-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075116-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075116-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075116-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075116-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075116-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075116-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075116-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075116-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075116-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075116-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075116-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075116-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075116-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075116-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075116-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075116-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075116-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075116-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075116-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075116-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075116-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075116-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075116-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075116-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075116-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075116-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075116-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075116-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075116-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075116-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A075116-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A075116-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A075116-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-23d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075116-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075116-002AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075116-003AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075116-004AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075116-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075116-002AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075116-003AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075116-004AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075116-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075116-002AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075116-003AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075116-004AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075116-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075116-002AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075116-003AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075116-004AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075116-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075116-002AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075116-003AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075116-004AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075116-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075116-002AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075116-003AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075116-004AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075116-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075116-002AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075116-003AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075116-004AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075116-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075116-002AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075116-003AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075116-004AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075116-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075116-002AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075116-003AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075116-004AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075116-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A075116-002AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A075116-003AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A075116-004AB31d06236e962d9…

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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions090aa3a9-910e-4f96-b748-783109aa96e62025-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075116
application number: ANDA075116
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc1ef9e90-6ff0-4ee5-86a3-1efee9c367892025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075116
application number: ANDA075116
ndc (product): 71335-0634
ndc (product): 71335-0867
ndc (product): 71335-1389
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEOCEANSIDE PHARMACEUTICALS43892b97-449d-45bc-bb09-29d47c655d652025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075116
application number: ANDA075116
ndc (product): 68682-993
ndc (product): 68682-998
ndc (product): 68682-997
ndc (product): 68682-994
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENuCare Pharmaceuticals,Inc.54b0b11d-adc0-4afb-e054-00144ff88e882024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075116
application number: ANDA075116
ndc (product): 68071-4005
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENuCare Pharmaceuticals,Inc.7cdb473a-e6d5-48e8-e053-2a91aa0aaeb72024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075116
application number: ANDA075116
ndc (product): 68071-4664
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack609e97e5-ebc7-4268-84ea-f279284c89e22020-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075116
application number: ANDA075116
ndc (product): 71335-0643

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8127Diltiazem HydrochlorideDiltiazem hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8127Diltiazem HydrochlorideDiltiazem hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8128Diltiazem HydrochlorideDiltiazem HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8128Diltiazem HydrochlorideDiltiazem HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8129Diltiazem HydrochlorideDiltiazem HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8129Diltiazem HydrochlorideDiltiazem HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
33261-829Diltiazem HydrochlorideDiltiazem HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
50090-1576Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-3062Diltiazem HydrochlorideDiltiazem HydrochlorideA-S Medication SolutionsANDACurrent
50090-3062Diltiazem HydrochlorideDiltiazem HydrochlorideA-S Medication SolutionsANDACurrent
63629-3564Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
68071-4005Diltiazem HydrochlorideDiltiazem HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4005Diltiazem HydrochlorideDiltiazem HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4155Diltiazem HydrochlorideDiltiazem HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4155Diltiazem HydrochlorideDiltiazem HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4371Diltiazem HydrochlorideDiltiazem hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4371Diltiazem HydrochlorideDiltiazem hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4664Diltiazem HydrochlorideDiltiazem hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4664Diltiazem HydrochlorideDiltiazem hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68682-993Diltiazem HydrochlorideDiltiazem hydrochlorideOCEANSIDE PHARMACEUTICALSANDACurrent
68682-993Diltiazem HydrochlorideDiltiazem hydrochlorideOCEANSIDE PHARMACEUTICALSANDACurrent
68682-994Diltiazem HydrochlorideDiltiazem HydrochlorideOCEANSIDE PHARMACEUTICALSANDACurrent
68682-994Diltiazem HydrochlorideDiltiazem HydrochlorideOCEANSIDE PHARMACEUTICALSANDACurrent
68682-997Diltiazem HydrochlorideDiltiazem HydrochlorideOCEANSIDE PHARMACEUTICALSANDACurrent
68682-997Diltiazem HydrochlorideDiltiazem HydrochlorideOCEANSIDE PHARMACEUTICALSANDACurrent
68682-998Diltiazem HydrochlorideDiltiazem HydrochlorideOCEANSIDE PHARMACEUTICALSANDACurrent
68682-998Diltiazem HydrochlorideDiltiazem HydrochlorideOCEANSIDE PHARMACEUTICALSANDACurrent
70518-2088Diltiazem HydrochlorideDiltiazem HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0634Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
71335-0634Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
71335-0643Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
71335-0643Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
71335-0867Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
71335-0867Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
71335-1389Diltiazem HydrochlorideDiltiazem hydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30761ORIG1999-12-23