Application 074910

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	60MG	No	No
002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	90MG	No	No
003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	No	Yes

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

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	TE codes	RLD / RS	Approval date
A074910-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02
A074910-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02
A074910-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A074910-001	AB1
A074910-002	AB1
A074910-003	AB1

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 · 123 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	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 109 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	A074910-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074910-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074910-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074910-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074910-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074910-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074910-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074910-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074910-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074910-001	AB1	1	`8072bd15b7f6…`

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
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Safecor Health LLC	fc02db0f-5311-4b61-896e-bfe340832735	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074910 application number: ANDA074910
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	ec7e93b8-666c-4d2f-8d08-07931e09f748	2025-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074910 application number: ANDA074910 ndc (product): 0378-6090 ndc (product): 0378-6060 ndc (product): 0378-6120
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Mylan Institutional Inc.	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074910 application number: ANDA074910 ndc (product): 51079-924 ndc (product): 51079-926 ndc (product): 51079-925
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Coupler LLC	2ced821f-19a6-4c7e-e063-6394a90adb80	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074910 application number: ANDA074910

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6060	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6060	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6060	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6060	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6060	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6090	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6090	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6090	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6090	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6090	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6120	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6120	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6120	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6120	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6120	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-924	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-924	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-924	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-924	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-925	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-925	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-925	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-925	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-926	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-926	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-926	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-926	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22382	ORIG	2003-07-28