Application 021392

Type: NDA
Sponsor: BAUSCH

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021392-001	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-002	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-003	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-004	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-005	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-006	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021392-001	AB
N021392-002	AB
N021392-003	AB
N021392-004	AB
N021392-005	AB
N021392-006	AB

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 · 252 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
2026-08-18 06:07:40	2026-07	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021392-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021392-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021392-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021392-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021392-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021392-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021392-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021392-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-004	AB	1	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021392-001	7108866	2019-12-17	U-107	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-001	6923984	2021-02-25		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-002	7108866	2019-12-17	U-107	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-002	6923984	2021-02-25		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-003	7108866	2019-12-17	U-107	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-003	6923984	2021-02-25		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-004	7108866	2019-12-17	U-107	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-004	6923984	2021-02-25		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-005	7108866	2019-12-17	U-107	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-005	6923984	2021-02-25		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-006	7108866	2019-12-17	U-107	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-006	6923984	2021-02-25		Drug product	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021392-001	6923984	2021-02-25		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021392-002	6923984	2021-02-25		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021392-003	6923984	2021-02-25		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021392-004	6923984	2021-02-25		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021392-005	6923984	2021-02-25		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021392-006	6923984	2021-02-25		Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021392-001	6923984	2021-02-25		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021392-002	6923984	2021-02-25		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021392-003	6923984	2021-02-25		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021392-004	6923984	2021-02-25		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021392-005	6923984	2021-02-25		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021392-006	6923984	2021-02-25		Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021392-001	6923984	2021-02-25		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021392-002	6923984	2021-02-25		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021392-003	6923984	2021-02-25		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021392-004	6923984	2021-02-25		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021392-005	6923984	2021-02-25		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021392-006	6923984	2021-02-25		Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021392-001	6923984	2021-02-25		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021392-002	6923984	2021-02-25		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021392-003	6923984	2021-02-25		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021392-004	6923984	2021-02-25		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021392-005	6923984	2021-02-25		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021392-006	6923984	2021-02-25		Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021392-001	6923984	2021-02-25		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021392-002	6923984	2021-02-25		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021392-003	6923984	2021-02-25		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021392-004	6923984	2021-02-25		Drug product	`c0c555d07b60…`

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
Cardizem LA	DILTIAZEM HYDROCHLORIDE	Bausch Health US LLC	3e180dc7-c871-4efc-8755-cae882976c8d	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021392 application number: NDA021392 ndc (product): 0187-2049 ndc (product): 0187-2048 ndc (product): 0187-2047 ndc (product): 0187-2046 ndc (product): 0187-2050 ndc (product): 0187-2045
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS	Oceanside Pharmaceuticals	73b3607a-99d0-44d8-92ef-0074684c9d7d	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021392 application number: NDA021392 ndc (product): 68682-709 ndc (product): 68682-705 ndc (product): 68682-708 ndc (product): 68682-706 ndc (product): 68682-704 ndc (product): 68682-707

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-2045	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2045	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2045	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2045	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-2046	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2046	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2046	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2046	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-2047	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2047	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2047	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2047	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-2048	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2048	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2048	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2048	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-2049	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2049	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2049	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2049	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-2050	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2050	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2050	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2050	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	NDA	Current
68682-704	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-704	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-705	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-705	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-705	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-706	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-706	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-706	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-707	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-707	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-707	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-708	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-708	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-708	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-709	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-709	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-709	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
70518-2451	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2451	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2451	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2451	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2451	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81965	SUPPL	2025-04-24
81964	SUPPL	2025-04-24
45917	SUPPL	2016-11-22
45937	SUPPL	2016-11-21
15352	SUPPL	2015-04-14
27649	SUPPL	2015-03-25
27648	SUPPL	2010-11-30
36809	SUPPL	2010-11-22
21631	SUPPL	2007-07-06
15351	SUPPL	2007-05-01
5239	SUPPL	2007-05-01
21630	ORIG	2005-06-27
27647	SUPPL	2004-04-07
15350	SUPPL	2004-04-05
15349	ORIG	2003-02-06