Application 208783

Type
ANDA
Sponsor
NOVAST LABS

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
005DILTIAZEM HYDROCHLORIDEDILTIAZEM 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
A208783-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14
A208783-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14
A208783-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14
A208783-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14
A208783-005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A208783-001AB3
A208783-002AB3
A208783-003AB3
A208783-004AB3
A208783-005AB3

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208783-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208783-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208783-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208783-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208783-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208783-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208783-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208783-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208783-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208783-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208783-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208783-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208783-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208783-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208783-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208783-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208783-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208783-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208783-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208783-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208783-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208783-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208783-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208783-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208783-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208783-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208783-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208783-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208783-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208783-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208783-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208783-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208783-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208783-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208783-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208783-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208783-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208783-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208783-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208783-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-145bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208783-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208783-002AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208783-003AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208783-004AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208783-005AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208783-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208783-002AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208783-003AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208783-004AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208783-005AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208783-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208783-002AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208783-003AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208783-004AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208783-005AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208783-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208783-002AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208783-003AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208783-004AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208783-005AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208783-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208783-002AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208783-003AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208783-004AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208783-005AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208783-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208783-002AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208783-003AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208783-004AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208783-005AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208783-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208783-002AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208783-003AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208783-004AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208783-005AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208783-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208783-002AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208783-003AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208783-004AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208783-005AB315bbf6a4d5a75…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackec928ee5-0809-4ba5-82ca-ecfed99ebb5a2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
ndc (product): 71335-1776
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEREMEDYREPACK INC.5e935265-d0fc-4223-835f-72426eeea6c42026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
ndc (product): 70518-3484
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEPreferred Pharmaceuticals Inc.3d594530-885f-45c7-b8a5-fd7e503ff83f2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
ndc (product): 68788-7870
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacka469b24a-fbec-4a2d-8b4c-b62c2b2c66f62026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacke6d9397c-f8a2-42d6-88ca-55060b1d073a2025-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack9041cc05-29d2-41ca-a368-e953bf3443b52025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
ndc (product): 71335-2089
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack0089fc7a-a7aa-4873-b699-39a1b21616ca2025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
ndc (product): 71335-1897
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEIngenus Pharmaceuticals, LLC355f560a-8ebb-4661-ad74-2a22f707d7f82025-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
ndc (product): 50742-248
ndc (product): 50742-251
ndc (product): 50742-249
ndc (product): 50742-250
ndc (product): 50742-252
Diltiazem HCL ERDILTIAZEM HCL ERDirect_Rxf1ea85b2-ecd2-5867-e053-2a95a90a24dc2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
ndc (product): 72189-409
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs70f167a1-ec7f-4969-b446-166af3e52c052024-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
ndc (product): 0615-8380
ndc (product): 0615-8381
ndc (product): 0615-8379

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8379diltiazem hydrochloridediltiazem hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8380diltiazem hydrochloridediltiazem hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8381diltiazem hydrochloridediltiazem hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
50742-248diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-248diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-248diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-248diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-249diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-249diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-249diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-249diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-250diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-250diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-250diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-250diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-251diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-251diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-251diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-251diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-252diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-252diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-252diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-252diltiazem hydrochloridediltiazem hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
68788-7870diltiazem hydrochloridediltiazem hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7870diltiazem hydrochloridediltiazem hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-3484diltiazem hydrochloridediltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-1776diltiazem hydrochloridediltiazem hydrochlorideBryant Ranch PrepackANDACurrent
71335-1776diltiazem hydrochloridediltiazem hydrochlorideBryant Ranch PrepackANDACurrent
71335-1897diltiazem hydrochloridediltiazem hydrochlorideBryant Ranch PrepackANDACurrent
71335-2089diltiazem hydrochloridediltiazem hydrochlorideBryant Ranch PrepackANDACurrent
72189-409CardizemDiltiazem HCL ERDirect_RxANDACurrent