Application 216521

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	TABLET;ORAL	90MG	No	No
004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	TABLET;ORAL	120MG	No	No

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

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
A216521-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23
A216521-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23
A216521-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23
A216521-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216521-001	AB
A216521-002	AB
A216521-003	AB
A216521-004	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 3 · 104 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
2026-02-19 14:30 UTC	2026-02	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 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	A216521-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216521-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216521-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216521-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216521-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216521-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216521-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216521-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216521-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216521-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216521-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216521-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216521-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216521-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216521-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216521-004	AB	1	`d06236e962d9…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	50df9f09-aa2f-495d-a25c-7c5c0fdffcf0	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	76e04232-b3da-48e8-a944-5f4f97a508df	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Northwind Health Company, LLC	106b33e3-b199-e555-e063-6294a90a5af5	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Northwind Health Company, LLC	09a5d332-347b-e73d-e063-6294a90a67ed	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc	196fc367-330e-4d15-b1d6-084ad3f97ae7	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521 ndc (product): 50228-484 ndc (product): 50228-483 ndc (product): 50228-481 ndc (product): 50228-482
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Coupler LLC	3418eb02-117e-a71a-e063-6394a90a826e	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Coupler LLC	2cd92b83-075e-b069-e063-6294a90a9fff	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	88b150a6-4c8d-49c8-88df-f3606c335472	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50228-481	Diltiazem Hydrochloride	Diltiazem hydrochloride	ScieGen Pharmaceuticals, Inc	ANDA	Current
50228-482	Diltiazem Hydrochloride	Diltiazem Hydrochloride	ScieGen Pharmaceuticals, Inc	ANDA	Current
50228-483	Diltiazem Hydrochloride	Diltiazem Hydrochloride	ScieGen Pharmaceuticals, Inc	ANDA	Current
50228-484	Diltiazem Hydrochloride	Diltiazem Hydrochloride	ScieGen Pharmaceuticals, Inc	ANDA	Current