Application 206641

Type
ANDA
Sponsor
ZYDUS 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
006DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL420MGNoNo

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

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
A206641-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11
A206641-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11
A206641-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11
A206641-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11
A206641-005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11
A206641-006DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206641-001AB4
A206641-002AB4
A206641-003AB4
A206641-004AB4
A206641-005AB4
A206641-006AB4

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206641-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-1184e616aacf4f…
2026-09-14 22:38:342026-08A206641-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-1184e616aacf4f…
2026-09-14 22:38:342026-08A206641-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-1184e616aacf4f…
2026-09-14 22:38:342026-08A206641-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-1184e616aacf4f…
2026-09-14 22:38:342026-08A206641-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-1184e616aacf4f…
2026-09-14 22:38:342026-08A206641-006DILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-1184e616aacf4f…
2026-08-18 06:07:402026-07A206641-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A206641-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A206641-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A206641-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A206641-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A206641-006DILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206641-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206641-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206641-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206641-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206641-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206641-006DILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206641-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206641-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206641-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206641-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206641-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206641-006DILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206641-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206641-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206641-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206641-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206641-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206641-006DILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206641-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206641-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206641-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206641-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206641-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206641-006DILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206641-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206641-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206641-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206641-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB42017-08-11b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206641-001AB4184e616aacf4f…
2026-09-14 22:38:342026-08A206641-002AB4184e616aacf4f…
2026-09-14 22:38:342026-08A206641-003AB4184e616aacf4f…
2026-09-14 22:38:342026-08A206641-004AB4184e616aacf4f…
2026-09-14 22:38:342026-08A206641-005AB4184e616aacf4f…
2026-09-14 22:38:342026-08A206641-006AB4184e616aacf4f…
2026-08-18 06:07:402026-07A206641-001AB41caaa826d4ba7…
2026-08-18 06:07:402026-07A206641-002AB41caaa826d4ba7…
2026-08-18 06:07:402026-07A206641-003AB41caaa826d4ba7…
2026-08-18 06:07:402026-07A206641-004AB41caaa826d4ba7…
2026-08-18 06:07:402026-07A206641-005AB41caaa826d4ba7…
2026-08-18 06:07:402026-07A206641-006AB41caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206641-001AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206641-002AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206641-003AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206641-004AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206641-005AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206641-006AB41011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206641-001AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206641-002AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206641-003AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206641-004AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206641-005AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206641-006AB4131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206641-001AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206641-002AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206641-003AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206641-004AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206641-005AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206641-006AB416a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206641-001AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206641-002AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206641-003AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206641-004AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206641-005AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206641-006AB41fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206641-001AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206641-002AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206641-003AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206641-004AB41b8a1b40f171c…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIADYLT ERDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackb4b4e53e-fc99-4f34-abc2-57e4f28aff842025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206641
application number: ANDA206641
TIADYLT ERDILTIAZEM HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.1278cd76-b8e9-42d9-ad19-6858e72cf9f22025-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206641
application number: ANDA206641
ndc (product): 68382-749
ndc (product): 68382-745
ndc (product): 68382-750
ndc (product): 68382-748
ndc (product): 68382-746
ndc (product): 68382-747
TIADYLT ERDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limitedd88e3546-3984-4dc9-893a-a29e958045502025-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206641
application number: ANDA206641
ndc (product): 70771-1040
ndc (product): 70771-1036
ndc (product): 70771-1038
ndc (product): 70771-1037
ndc (product): 70771-1039
ndc (product): 70771-1035

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 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-745TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-745TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-745TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-746TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-746TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-746TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-747TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-747TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-747TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-748TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-748TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-748TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-749TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-749TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-749TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-750TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-750TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-750TIADYLT ERdiltiazem hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1035TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1035TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1035TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1036TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1036TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1036TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1037TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1037TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1037TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1038TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1038TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1038TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1039TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1039TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1039TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1040TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1040TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1040TIADYLT ERdiltiazem hydrochlorideCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49481ORIG2017-08-21