Application 007529

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	QUINIDINE GLUCONATE	QUINIDINE GLUCONATE	INJECTABLE;INJECTION	80MG/ML	Yes	No

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
N007529-002	QUINIDINE GLUCONATE	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION		RLD	1989-02-10

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N007529-002	QUINIDINE GLUCONATE	80MG/ML	INJECTABLE / INJECTION	RLD	1989-02-10	`cb3db0bc1861…`

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 · 3 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	Name fallback brand name: Quinidine Gluconate generic name: QUINIDINE GLUCONATE
Quinidine gluconate	QUINIDINE GLUONATE	Eywa Pharma Inc	4db375a3-0cff-4fa7-af7a-2a49e0b922d0	2021-12-29	Warnings, Adverse reactions	Name fallback brand name: Quinidine gluconate
Quinidine Gluconate	QUINIDINE GLUCONATE	Sun Pharmaceutical Industries, Inc.	5023f053-fcc4-4c2c-aa59-9ec198ad185e	2018-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quinidine Gluconate generic name: QUINIDINE GLUCONATE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-1407	Quinidine Gluconate	Quinidine Gluconate	Eli Lilly and Company	NDA	Current