Application 020401

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIAZAC	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	Yes	No
002	TIAZAC	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	180MG	Yes	No
003	TIAZAC	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	240MG	Yes	No
004	TIAZAC	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	300MG	Yes	No
005	TIAZAC	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	360MG	Yes	No
006	TIAZAC	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	420MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020401-001	TIAZAC	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-002	TIAZAC	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-003	TIAZAC	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-004	TIAZAC	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-005	TIAZAC	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-006	TIAZAC	DILTIAZEM HYDROCHLORIDE	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020401-001	AB4
N020401-002	AB4
N020401-003	AB4
N020401-004	AB4
N020401-005	AB4
N020401-006	AB4

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 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020401-001	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-002	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-003	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-004	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-005	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-006	AB4	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-001	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-002	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-003	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-004	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-005	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-006	AB4	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020401-001	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-002	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-003	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-004	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-005	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-006	AB4	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-001	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-002	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-003	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-004	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-005	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-006	AB4	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-001	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-002	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-003	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-004	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-005	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-006	AB4	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-001	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-002	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-003	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-004	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-005	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-006	AB4	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-001	AB4	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-002	AB4	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-003	AB4	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-004	AB4	1	`2680178bc6a6…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TIAZAC EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bausch Health US, LLC	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	58eeb8bc-91d0-4cf8-a0d7-be3548d92196	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Oceanside Pharmaceuticals	862d65cb-a732-4786-b569-bad2eaafddfd	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	c7c6a74e-5f73-4265-a0e0-8fd2cd26909e	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401
DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE	direct rx	c7cf9276-4b4c-10b2-e053-2995a90a3738	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401 ndc (product): 72189-248

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72189-248	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE	direct rx	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82018	SUPPL	2025-04-28
81954	SUPPL	2025-04-24
45915	SUPPL	2016-11-22
45939	SUPPL	2016-11-21
24906	SUPPL	2010-11-30
34601	SUPPL	2010-11-22
2476	SUPPL	2007-07-05
41336	SUPPL	2001-12-04
20632	SUPPL	2001-06-06
41335	SUPPL	1998-01-30