Application 040104

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET;ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040104-001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040104-001AB

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3084e616aacf4f…
2026-08-18 06:07:402026-07A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-303f01610625f2…
2019-09-15 20:21 UTC2019-09A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A040104-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A040104-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040104-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040104-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040104-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040104-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040104-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040104-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040104-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040104-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040104-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040104-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040104-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040104-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040104-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040104-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040104-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040104-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040104-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040104-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040104-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040104-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040104-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040104-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040104-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040104-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040104-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040104-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040104-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040104-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040104-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040104-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040104-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040104-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040104-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040104-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040104-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040104-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040104-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040104-001AB1f41ea6bd6efb…

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 2 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepack84957919-ca14-4c3d-b4fe-452ff330dd7a2025-10-02Warnings, Adverse reactionsName fallback
brand name: HYDROXYCHLOROQUINE SULFATE
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATENuCare Pharmaceuticals,Inc.b8e3a352-a1e3-e672-e053-2a95a90a641c2025-08-15Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions6a06ad3d-2d6c-4e51-93f5-8f782b86975b2025-05-09Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEAurobindo Pharma Limitede6f889ff-c5ba-4324-b87c-ec3ac942be2f2025-03-11Warnings, Adverse reactionsName fallback
brand name: HYDROXYCHLOROQUINE SULFATE
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATECoupler LLC2eeaf562-95f9-bcef-e063-6394a90a1c192025-02-24Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEIpca Laboratories Limited9dfa0ff8-e8cf-47f9-847a-b86f23dc39df2024-11-19Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions3817387f-2fc8-4f39-8096-3b48fff57ab02024-10-15Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions53553ef5-5f44-4d39-ae8c-c9a632cc84162024-10-15Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
SOVUNAHYDROXYCHLOROQUINE SULFATEANI Pharmaceuticals, Inc.dd441154-b196-4d4c-bc56-2e37f345ef8d2024-10-08Warnings, Adverse reactionsName fallback
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEAsclemed USA, Inc.19816051-c25e-44b5-a127-e846dbd0a8d82024-09-05Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepack2c109188-d28b-4c65-8b52-819bd8547f2e2024-08-16Warnings, Adverse reactionsName fallback
brand name: HYDROXYCHLOROQUINE SULFATE
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEAmerican Health Packaginga2d7be5a-98ee-4292-8715-46573dbe1c5b2024-08-01Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepackf618a091-ade1-4c39-ab76-f6218b606e052024-07-09Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATENCS HealthCare of KY, LLC dba Vangard Labs83cb17e9-ce57-48aa-b92c-ac0dee92d5bc2024-06-21Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEAmneal Pharmaceuticals NY LLC6a9e2fc8-bedf-46d4-9973-328dbcb180612024-06-11Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions1a1fb21d-a01c-4d50-8764-cdd6c20d95692024-05-30Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATERising Pharma Holdings, Inc.6837f2aa-1349-4b45-a0ac-09ec914fd7642024-05-06Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepackcf4b1912-9806-4ef3-bf17-152a96d75bbc2024-04-05Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
PlaquenilHYDROXYCHLOROQUINE SULFATEAphena Pharma Solutions - Tennessee, LLCeb26c050-fc41-4183-9f8c-86351335fa642024-04-04Warnings, Adverse reactionsName fallback
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATETeva Pharmaceuticals USA, Inc.5f3e49b2-dc11-40a9-b366-c88e36a471e52024-02-29Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE

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 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8218Hydroxychloroquine SulfateHydroxychloroquine SulfateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8218Hydroxychloroquine SulfateHydroxychloroquine SulfateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-1407Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0904-6508Hydroxychloroquine SulfateHydroxychloroquine SulfateMajor PharmaceuticalsANDACurrent
0904-6884Hydroxychloroquine SulfateHydroxychloroquine SulfateMajor PharmaceuticalsANDACurrent
0904-6884Hydroxychloroquine SulfateHydroxychloroquine SulfateMajor PharmaceuticalsANDACurrent
0904-6884Hydroxychloroquine SulfateHydroxychloroquine SulfateMajor PharmaceuticalsANDACurrent
16714-474Hydroxychloroquine SulfateHydroxychloroquine SulfateNorthstar RxLLCANDACurrent
16714-753Hydroxychloroquine SulfateHydroxychloroquine SulfateNorthstar RxLLCANDACurrent
16714-753Hydroxychloroquine SulfateHydroxychloroquine SulfateNorthstar RxLLCANDACurrent
16714-753Hydroxychloroquine SulfateHydroxychloroquine SulfateNorthstar RxLLCANDACurrent
16714-753Hydroxychloroquine SulfateHydroxychloroquine SulfateNorthstar RxLLCANDACurrent
16714-753Hydroxychloroquine SulfateHydroxychloroquine SulfateNorthstar RxLLCANDACurrent
43353-103Hydroxychloroquine SulfateHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67296-1780Hydroxychloroquine SulfateHydroxychloroquine SulfateRedPharm Drug, Inc.ANDACurrent
67296-1780Hydroxychloroquine SulfateHydroxychloroquine SulfateRedPharm Drug, Inc.ANDACurrent
71610-047Hydroxychloroquine SulfateHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-047Hydroxychloroquine SulfateHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62483SUPPL2020-04-08
62482SUPPL2020-04-08