Application 088072

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUINIDINE SULFATE	QUINIDINE SULFATE	TABLET;ORAL	300MG	No	No
002	QUINIDINE SULFATE	QUINIDINE SULFATE	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088072-001	QUINIDINE SULFATE	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26
A088072-002	QUINIDINE SULFATE	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982

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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL	AB		1983-09-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL	AB	Approved before 1982		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL	AB		1983-09-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL	AB	Approved before 1982		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL	AB		1983-09-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL	AB	Approved before 1982		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL	AB		1983-09-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL	AB	Approved before 1982		`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088072-001	QUINIDINE SULFATE	300MG	TABLET / ORAL		RS	1983-09-26	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088072-002	QUINIDINE SULFATE	200MG	TABLET / ORAL		RS, Approved before 1982		`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A088072-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A088072-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A088072-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A088072-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088072-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A088072-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088072-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A088072-002	AB	1	`ea99ee380514…`

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
QUINIDINE SULFATE	QUINIDINE SULFATE TABLET	EPIC PHARMA, LLC	b0d6341b-d880-4f0b-8844-bc788c03004a	2023-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088072 application number: ANDA088072 ndc (product): 42806-512 ndc (product): 42806-513

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-1047	Quinidine Sulfate	Quinidine Sulfate	Eon Labs, Inc.	ANDA	Current
0185-1047	Quinidine Sulfate	Quinidine Sulfate	Eon Labs, Inc.	ANDA	Current
0185-1047	Quinidine Sulfate	Quinidine Sulfate	Eon Labs, Inc.	ANDA	Current
0185-4346	Quinidine Sulfate	Quinidine Sulfate	Eon Labs, Inc.	ANDA	Current
0185-4346	Quinidine Sulfate	Quinidine Sulfate	Eon Labs, Inc.	ANDA	Current
0185-4346	Quinidine Sulfate	Quinidine Sulfate	Eon Labs, Inc.	ANDA	Current
42806-512	QUINIDINE SULFATE	quinidine sulfate tablet	EPIC PHARMA, LLC	ANDA	Current
42806-513	QUINIDINE SULFATE	quinidine sulfate tablet	EPIC PHARMA, LLC	ANDA	Current