Application 205231

Type
ANDA
Sponsor
TWI PHARMS

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 42.

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
A205231-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30
A205231-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30
A205231-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30
A205231-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30
A205231-005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205231-001AB3
A205231-002AB3
A205231-003AB3
A205231-004AB3
A205231-005AB3

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 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-302680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205231-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-002AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-003AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-004AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-005AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205231-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-002AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-003AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-004AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-005AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-002AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-003AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-004AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-005AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205231-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-002AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-003AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-004AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-005AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-002AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-003AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-004AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-005AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-002AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-003AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-004AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-005AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-002AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-003AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-004AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-005AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-002AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-003AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-004AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-005AB312680178bc6a6…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMajor Pharmaceuticalse7476adc-a940-4e76-a1dd-c418de493bc02026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
ndc (product): 0904-7220
ndc (product): 0904-7218
ndc (product): 0904-7219
ndc (product): 0904-7217
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions465dbab3-f201-4441-8f55-92a843b5134f2026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
ndc (product): 50090-5466
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEGolden State Medical Supply, Inc.c9f17187-e958-106b-e053-2a95a90a54d82026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
ndc (product): 51407-473
ndc (product): 51407-476
ndc (product): 51407-474
ndc (product): 51407-475
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECardinal Health 107, LLCbdb9e7cf-bfbb-48b4-a8be-9038820d82792026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEUpsher-Smith Laboratories, LLCbb32d681-9a83-431e-9984-a5cee2c948522026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
ndc (product): 24979-027
ndc (product): 24979-029
ndc (product): 24979-026
ndc (product): 24979-028
ndc (product): 24979-030
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions839af3af-4040-4cf4-8d4a-881a053514cc2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
ndc (product): 50090-5452
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack22e653e5-4122-4d7d-b9ad-0bdc1390fb402025-10-20Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
ndc (product): 71335-2129
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc8809dc9-b99b-4d30-a7da-0bc21aa90f9c2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutionsf317de31-495c-4268-8171-89534bf1dd362024-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
ndc (product): 50090-5416

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7217Diltiazem HydrochlorideDiltiazem hydrochlorideMajor PharmaceuticalsANDACurrent
0904-7218Diltiazem HydrochlorideDiltiazem hydrochlorideMajor PharmaceuticalsANDACurrent
0904-7219Diltiazem HydrochlorideDiltiazem hydrochlorideMajor PharmaceuticalsANDACurrent
0904-7220Diltiazem HydrochlorideDiltiazem hydrochlorideMajor PharmaceuticalsANDACurrent
24979-026Diltiazem HydrochlorideDiltiazem hydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-027Diltiazem HydrochlorideDiltiazem hydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-028Diltiazem HydrochlorideDiltiazem hydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-029Diltiazem HydrochlorideDiltiazem hydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-030Diltiazem HydrochlorideDiltiazem hydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
50090-5416Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-5416Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-5452Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-5452Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-5466Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-5466Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-5466Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
51407-473Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-473Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-474Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-474Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-475Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-475Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-476Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-476Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
70518-2506Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2506Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2506Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2506Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2789Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2789Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3337Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70934-564Diltiazem HydrochlorideDiltiazem hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-565Diltiazem HydrochlorideDiltiazem hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-2129Diltiazem HydrochlorideDiltiazem hydrochlorideBryant Ranch PrepackANDACurrent