Application 075124

Type: ANDA
Sponsor: MYLAN

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A075124-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18
A075124-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18
A075124-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075124-002	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075124-003	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075124-001	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	1998-03-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A075124-001	AB2	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075124-003	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075124-001	AB2	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075124-002	AB2	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075124-003	AB2	1	`ea99ee380514…`

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 6 of 6 · 109 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	eed8cfeb-6ec7-4914-b8e0-a5c3d623c9a4	2023-11-20	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	eebf29fe-ce22-4482-b850-5854550bf2c4	2023-08-04	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	225a87fb-d353-4ee7-bd08-14d631ff6b16	2023-06-07	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9f69371d-3ede-285d-e053-2a95a90a6e42	2023-05-30	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Proficient Rx LP	a24255a3-88b1-47ef-90fc-51619a1c5a63	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	5460158f-7782-45f4-89b1-f84e6ba178d8	2023-01-17	Warnings, Adverse reactions	Name fallback brand name: Diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	6f71ba5e-7bd6-409a-80c6-2f22d975aefc	2023-01-09	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Oceanside Pharmaceuticals	f6a24de7-8ffe-48af-873f-10fdcd5551d1	2020-06-02	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	609e97e5-ebc7-4268-84ea-f279284c89e2	2020-01-19	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5220	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5220	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5280	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5280	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5340	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5340	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
43063-619	Diltiazem Hydrochloride	diltiazem hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
51079-947	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
55289-853	Diltiazem Hydrochloride	diltiazem hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39455	ORIG	1998-03-18
22419	ORIG	1998-03-18
8528	ORIG	1998-03-18