FDA.reportPublic FDA data

Application 009768

Type
NDA
Sponsor
CONCORDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PLAQUENILHYDROXYCHLOROQUINE SULFATETABLET;ORAL200MGYesYes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N009768-001PLAQUENILHYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N009768-001AB

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N009768-001PLAQUENIL200MGTABLET / ORALABRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N009768-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08N009768-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N009768-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N009768-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009768-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N009768-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009768-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009768-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009768-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N009768-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N009768-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N009768-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N009768-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N009768-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N009768-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N009768-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N009768-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N009768-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N009768-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N009768-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N009768-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N009768-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N009768-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N009768-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N009768-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N009768-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N009768-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N009768-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N009768-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N009768-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N009768-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N009768-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N009768-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N009768-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N009768-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N009768-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N009768-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N009768-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N009768-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N009768-001AB13a93d1ddd44b…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PlaquenilHYDROXYCHLOROQUINE SULFATEAdvanz Pharma (US) Corp.34496b43-05a2-45fb-a769-52b12e0993412026-04-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 009768
application number: NDA009768
ndc (product): 59212-562
PlaquenilHYDROXYCHLOROQUINE SULFATEAphena Pharma Solutions - Tennessee, LLCeb26c050-fc41-4183-9f8c-86351335fa642024-04-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 009768
application number: NDA009768
ndc (product): 71610-473
PlaquenilHYDROXYCHLOROQUINE SULFATEProficient Rx LP8aec894d-5711-4079-b167-240713bf04f22020-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 009768
application number: NDA009768
ndc (product): 71205-448

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 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-335PlaquenilHydroxychloroquine SulfateAvKARE, Inc.NDACurrent
43353-051Hydroxychloroquine SulfateHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-051Hydroxychloroquine SulfateHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-997PlaquenilHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCNDACurrent
50090-3432Hydroxychloroquine SulfateHydroxychloroquine SulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
59212-562PlaquenilHydroxychloroquine SulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-562PlaquenilHydroxychloroquine SulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-562PlaquenilHydroxychloroquine SulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-562PlaquenilHydroxychloroquine SulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-562PlaquenilHydroxychloroquine SulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-562PlaquenilHydroxychloroquine SulfateConcordia Pharmaceuticals Inc.NDACurrent
63629-3343Hydroxychloroquine SulfateHydroxychloroquine SulfateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-3343Hydroxychloroquine SulfateHydroxychloroquine SulfateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-3343Hydroxychloroquine SulfateHydroxychloroquine SulfateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
66993-057Hydroxychloroquine SulfateHydroxychloroquine SulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-057Hydroxychloroquine SulfateHydroxychloroquine SulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-057Hydroxychloroquine SulfateHydroxychloroquine SulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-057Hydroxychloroquine SulfateHydroxychloroquine SulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-057Hydroxychloroquine SulfateHydroxychloroquine SulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
67296-1781PlaquenilHydroxychloroquine SulfateRedPharm Drug, Inc.NDACurrent
67296-1781PlaquenilHydroxychloroquine SulfateRedPharm Drug, Inc.NDACurrent
68151-0511PlaquenilHydroxychloroquine SulfateCarilion Materials ManagementNDACurrent
68788-7770Hydroxychloroquine SulfateHydroxychloroquine SulfatePreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-7770Hydroxychloroquine SulfateHydroxychloroquine SulfatePreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
71205-448PlaquenilHydroxychloroquine SulfateProficient Rx LPNDACurrent
71610-473PlaquenilHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCNDACurrent
71610-473PlaquenilHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76787SUPPL 2023-12-13
76777SUPPL 2023-12-13
74891SUPPL 2023-07-26
74887SUPPL 2023-07-25
70985SUPPL2022-05-04
70979SUPPL2022-05-04
67437SUPPL2021-05-07
67399SUPPL2021-05-04
59358SUPPL2019-07-16
59357SUPPL2019-07-16
47021SUPPL2017-01-30
47020SUPPL2017-01-30
47019SUPPL2017-01-30
47027SUPPL2017-01-27
47026SUPPL2017-01-27
47025SUPPL2017-01-27
11881SUPPL2007-07-05
33006SUPPL2007-06-27