Application 090421

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	No	No
002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	180MG	No	No
003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	240MG	No	No
004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	300MG	No	No
005	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	360MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090421-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15
A090421-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15
A090421-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15
A090421-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15
A090421-005	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15

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 6 · 215 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	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 165 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A090421-001	AB4	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090421-002	AB4	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090421-003	AB4	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090421-004	AB4	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090421-005	AB4	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090421-001	AB4	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090421-002	AB4	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090421-003	AB4	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090421-004	AB4	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090421-005	AB4	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090421-001	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090421-002	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090421-003	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090421-004	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090421-005	AB4	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090421-001	AB4	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090421-002	AB4	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090421-003	AB4	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090421-004	AB4	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090421-005	AB4	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090421-001	AB4	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090421-002	AB4	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090421-003	AB4	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090421-004	AB4	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090421-005	AB4	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090421-001	AB4	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090421-002	AB4	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090421-003	AB4	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090421-004	AB4	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090421-005	AB4	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090421-001	AB4	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090421-002	AB4	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090421-003	AB4	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090421-004	AB4	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090421-005	AB4	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090421-001	AB4	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090421-002	AB4	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090421-003	AB4	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090421-004	AB4	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090421-005	AB4	1	`8869cabd3fbd…`

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	Sun Pharmaceutical Industries, Inc.	eebf29fe-ce22-4482-b850-5854550bf2c4	2023-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090421 application number: ANDA090421 ndc (product): 47335-673 ndc (product): 47335-670 ndc (product): 47335-671 ndc (product): 47335-669 ndc (product): 47335-672

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-669	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-669	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-670	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-670	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-671	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-671	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-672	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-672	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-673	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-673	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
70518-2241	Diltiazem Hydrochloride	Diltiazem Hydrochloride	REMEDYREPACK INC.	ANDA	Current