Application 089338

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUINIDINE GLUCONATE	QUINIDINE GLUCONATE	TABLET, EXTENDED RELEASE;ORAL	324MG	No	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A089338-001	QUINIDINE GLUCONATE	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089338-001	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 2 · 41 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	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL		RS	1987-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL		RS	1987-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL		RS	1987-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL		RS	1987-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL		RS	1987-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL		RS	1987-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL		RS	1987-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL		RS	1987-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	BX	RS	1987-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	BX	RS	1987-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1987-02-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089338-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL		RS	1987-02-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089338-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089338-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089338-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089338-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089338-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089338-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089338-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089338-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089338-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089338-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089338-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089338-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089338-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089338-001	AB	1	`8072bd15b7f6…`
2022-04-04 05:41 UTC	2022-04	A089338-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A089338-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089338-001	AB	1	`782e0a99824c…`
2019-09-15 20:21 UTC	2019-09	A089338-001	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089338-001	BX	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089338-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089338-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089338-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089338-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089338-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089338-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089338-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089338-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089338-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089338-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089338-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089338-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A089338-001	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quinidine Gluconate	QUINIDINE GLUCONATE	Golden State Medical Supply	ad2ad985-cca2-25b5-e053-2995a90a402f	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089338 application number: ANDA089338 ndc (product): 51407-288
Quinidine Gluconate	QUINIDINE GLUCONATE	Sun Pharmaceutical Industries, Inc.	5023f053-fcc4-4c2c-aa59-9ec198ad185e	2018-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089338 application number: ANDA089338 ndc (product): 53489-141

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
51407-288	Quinidine Gluconate	Quinidine Gluconate	Golden State Medical Supply	ANDA	Current
53489-141	Quinidine Gluconate	Quinidine Gluconate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
54738-901	Quinidine Gluconate	Quinidine Gluconate	Richmond Pharmaceuticals, Inc.	ANDA	Current
68151-2701	Quinidine Gluconate	Quinidine Gluconate	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39599	SUPPL	2010-03-17