Application 074752

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074752-001	CARTIA XT	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09
A074752-002	CARTIA XT	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09
A074752-003	CARTIA XT	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09
A074752-004	CARTIA XT	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A074752-001	AB3
A074752-002	AB3
A074752-003	AB3
A074752-004	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 5 · 172 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	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A074752-001	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074752-002	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074752-003	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074752-004	AB3	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074752-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074752-002	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074752-003	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074752-004	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074752-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074752-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074752-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074752-004	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-004	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074752-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074752-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074752-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074752-004	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-004	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-004	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-004	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-004	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-004	AB3	1	`5bbf6a4d5a75…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cartia XT	DILTIAZEM HYDROCHLORIDE	Actavis Pharma, Inc.	2dc2b889-8443-4f7f-83be-86c68e179804	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074752 application number: ANDA074752 ndc (product): 62037-597 ndc (product): 62037-600 ndc (product): 62037-599 ndc (product): 62037-598
Cartia XT	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	de671934-25a8-4df6-b7a1-97e0337e9e2b	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074752 application number: ANDA074752 ndc (product): 63629-7896
Cartia XT	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	e02f5fad-6482-4d5d-91c5-0ae6b0ce15b8	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074752 application number: ANDA074752 ndc (product): 71335-0879
CARTIA XT	DILTIAZEM HYDROCHLORIDE	DirectRx	dbfda3a5-5602-6e47-e053-2995a90ac07b	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074752 application number: ANDA074752 ndc (product): 72189-344

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 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3051	Cartia	Diltiazem Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3051	Cartia	Diltiazem Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3124	Cartia	Diltiazem Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3124	Cartia	Diltiazem Hydrochloride	A-S Medication Solutions	ANDA	Current
62037-597	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-597	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-597	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-597	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-598	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-598	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-598	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-598	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-599	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-599	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-599	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-599	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-600	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-600	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-600	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-600	Cartia	Diltiazem Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
63629-7896	Cartia	Diltiazem Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7896	Cartia	Diltiazem Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7896	Cartia	Diltiazem Hydrochloride	Bryant Ranch Prepack	ANDA	Current
70518-1537	Cartia	Diltiazem Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1537	Cartia	Diltiazem Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1537	Cartia	Diltiazem Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0879	Cartia	Diltiazem Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0879	Cartia	Diltiazem Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0879	Cartia	Diltiazem Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72189-344	CARTIA XT	diltiazem hydrochloride	DirectRx	ANDA	Current
72189-344	CARTIA XT	diltiazem hydrochloride	DirectRx	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42875	SUPPL	2005-07-22
42874	SUPPL	2005-07-22
42873	SUPPL	2005-07-22
42872	SUPPL	2005-07-22
42871	SUPPL	2005-07-22
42870	SUPPL	2005-07-22
42869	SUPPL	2005-07-22
42868	SUPPL	2005-07-22
22366	SUPPL	2005-07-22
22365	SUPPL	2005-07-22
22364	SUPPL	2005-07-22
22363	SUPPL	2005-07-22
22362	SUPPL	2005-07-22
22361	SUPPL	2005-07-22
22360	SUPPL	2005-07-22
22359	SUPPL	2005-07-22
22358	ORIG	2005-07-22
30694	ORIG	1998-07-09
18365	ORIG	1998-07-09