Home Applications 021799 Application 021799
Type NDA
Sponsor SUN PHARM INDUSTRIES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QUALAQUIN QUININE SULFATE CAPSULE;ORAL 324MG Yes 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date N021799-001 QUALAQUIN QUININE SULFATE 324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-08-12
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UTC 2026-02 N021799-001 QUALAQUIN 324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL RLD 2005-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL RLD 2005-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL RLD 2005-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL RLD 2005-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL RLD 2005-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL RLD 2005-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL RLD 2005-08-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL RLD 2005-08-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL RLD 2005-08-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021799-001 QUALAQUIN 324MG CAPSULE / ORAL AB RLD, RS 2005-08-12 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 · 9 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join QUININE SULFATE QUININE SULFATE Lupin Pharmaceuticals, Inc. 1f32f05c-a215-40be-b951-e41a7b54a8a0 2025-10-31 Boxed warning, Warnings, Adverse reactions Name fallback generic name: QUININE SULFATE Quinine Sulfate QUININE SULFATE Teva Pharmaceuticals USA, Inc. e782283e-2608-4fd6-a8b2-6c30b9d5d3b0 2025-08-22 Boxed warning, Warnings, Adverse reactions Name fallback generic name: QUININE SULFATE QUININE SULFATE QUININE SULFATE Ingenus Pharmaceuticals, LLC b2f73c64-b92c-49bf-ad39-e32ac83e4d3d 2024-09-16 Boxed warning, Warnings, Adverse reactions Name fallback generic name: QUININE SULFATE Chininum sulphuricum QUININE SULFATE Boiron 8529596f-37e6-c44e-e053-2a91aa0ad014 2023-11-09 Name fallback generic name: QUININE SULFATE Chininum sulphuricum QUININE SULFATE Boiron 8528ead8-9d2c-c708-e053-2a91aa0a0e1a 2023-11-09 Name fallback generic name: QUININE SULFATE Chininum sulphuricum QUININE SULFATE Boiron 852910c8-1898-98f4-e053-2a91aa0af843 2023-11-09 Name fallback generic name: QUININE SULFATE Chininum sulphuricum QUININE SULFATE Boiron 33885950-2a55-11e7-8288-424c58303031 2023-11-09 Name fallback generic name: QUININE SULFATE Chininum sulphuricum QUININE SULFATE Boiron 852910c8-1896-98f4-e053-2a91aa0af843 2023-11-09 Name fallback generic name: QUININE SULFATE Chininum sulphuricum QUININE SULFATE Boiron 852910c8-189d-98f4-e053-2a91aa0af843 2023-06-05 Name fallback generic name: QUININE SULFATE
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 13310-153 Qualaquin Quinine Sulfate AR Scientific Inc. NDA Current 49708-153 Qualaquin Quinine Sulfate Sun Pharmaceutical Industries, Inc. NDA Current 49708-153 Qualaquin Quinine Sulfate Sun Pharmaceutical Industries, Inc. NDA Current 53489-700 Quinine Sulfate Quinine Sulfate Sun Pharmaceutical Industries, Inc. NDA AUTHORIZED GENERIC Current 53489-700 Quinine Sulfate Quinine Sulfate Sun Pharmaceutical Industries, Inc. NDA AUTHORIZED GENERIC Current 53489-700 Quinine Sulfate Quinine Sulfate Sun Pharmaceutical Industries, Inc. NDA AUTHORIZED GENERIC Current 68084-947 Quinine Sulfate Quinine Sulfate American Health Packaging NDA AUTHORIZED GENERIC Current 68084-947 Quinine Sulfate Quinine Sulfate American Health Packaging NDA AUTHORIZED GENERIC Current 68084-947 Quinine Sulfate Quinine Sulfate American Health Packaging NDA AUTHORIZED GENERIC Current 68084-947 Quinine Sulfate Quinine Sulfate American Health Packaging NDA AUTHORIZED GENERIC Current 71557-047 Qualaquin Quinine Sulfate Frontida BioPharm, Inc. NDA AUTHORIZED GENERIC Current