Application 074093

Type: ANDA
Sponsor: CHARTWELL MOLECULES

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 44.

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	Approval date
A074093-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05
A074093-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05
A074093-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05
A074093-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05

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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`3a93d1ddd44b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Chartwell RX, LLC	51abce7b-e3d1-44b5-bccc-d463150d0bba	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074093 application number: ANDA074093

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.