Application 203023

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	No	No
002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	180MG	No	No
003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	240MG	No	No
004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	300MG	No	No
005	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	360MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203023-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08
A203023-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08
A203023-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08
A203023-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08
A203023-005	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203023-005	AB3

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 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203023-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203023-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203023-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203023-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203023-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203023-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203023-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203023-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203023-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203023-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203023-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203023-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203023-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203023-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203023-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203023-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203023-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203023-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203023-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203023-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203023-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203023-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203023-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203023-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203023-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203023-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203023-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203023-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203023-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL		2017-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203023-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203023-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203023-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203023-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203023-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203023-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203023-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203023-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203023-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203023-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203023-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2017-06-08	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 190 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203023-005	AB3	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203023-005	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203023-005	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203023-005	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203023-005	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203023-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203023-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203023-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203023-005	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203023-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203023-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203023-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203023-004	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203023-005	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203023-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203023-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203023-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203023-004	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203023-005	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203023-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203023-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203023-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203023-004	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203023-005	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203023-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203023-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203023-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203023-004	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203023-005	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203023-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203023-002	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203023-003	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203023-004	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203023-005	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203023-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203023-002	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203023-003	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203023-004	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203023-005	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203023-001	AB3	1	`79d66fd596c7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	976d9dd0-4f11-4439-b84e-0c0f0e018d8b	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203023 application number: ANDA203023 ndc (product): 63304-722 ndc (product): 63304-720 ndc (product): 63304-719 ndc (product): 63304-718 ndc (product): 63304-721
Diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	5460158f-7782-45f4-89b1-f84e6ba178d8	2023-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203023 application number: ANDA203023

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6146	Diltiazem hydrochloride	Diltiazem hydrochloride	A-S Medication Solutions	ANDA	Current
63304-718	Diltiazem hydrochloride	Diltiazem hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-719	Diltiazem hydrochloride	Diltiazem hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-720	Diltiazem hydrochloride	Diltiazem hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-721	Diltiazem hydrochloride	Diltiazem hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-722	Diltiazem hydrochloride	Diltiazem hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current