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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-09-29 23:25 UTC2022-09A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-09-29 23:25 UTC2022-09A040104-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040104-001AB1cb3db0bc1861…

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 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepackda435181-0c5a-4188-8d59-51234116b0052026-06-29Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepack68d6439d-b927-47e6-86ef-20e572e819412026-06-08Warnings, Adverse reactionsName fallback
brand name: HYDROXYCHLOROQUINE SULFATE
generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATECardinal Health 107, LLCe5fe2ece-40a1-49eb-818f-62ff3c3bb1992026-06-03Warnings, Adverse reactionsName fallback
brand name: HYDROXYCHLOROQUINE SULFATE
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATECardinal Health 107, LLC6971241c-8323-456e-91a4-a404a9e100de2026-05-18Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEPreferred Pharmaceuticals, Inc.d6c8ee2e-116e-4167-8d1a-bd570a1ce6722026-05-11Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
PlaquenilHYDROXYCHLOROQUINE SULFATEAdvanz Pharma (US) Corp.34496b43-05a2-45fb-a769-52b12e0993412026-04-09Warnings, Adverse reactionsName fallback
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEAccord Healthcare, Inc.,84b00366-96ef-41e1-bac6-5d24acdb9e1d2026-04-01Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepack1a39c45e-dc14-4441-9b02-7329647bc5a42026-03-30Warnings, Adverse reactionsName fallback
brand name: HYDROXYCHLOROQUINE SULFATE
generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepack517ee47b-6abf-43cb-a4ca-c2e7827461a82026-03-16Warnings, Adverse reactionsName fallback
brand name: HYDROXYCHLOROQUINE SULFATE
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions87076a61-ce76-475b-ac6d-c33ba617195d2026-02-14Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepack37413f6b-fb68-4e0c-8bcc-c5b76e956dfc2026-02-13Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATENuCare Pharmaceuticals, Inc.4902343c-7d1b-ba70-e063-6294a90a36802026-01-22Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEAvPAKa5b3455a-e842-7d4b-e053-2995a90adee32026-01-08Warnings, Adverse reactionsName fallback
brand name: HYDROXYCHLOROQUINE SULFATE
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEAmneal Pharmaceuticals NY LLC7804f5d2-41a6-4523-a277-6967e984e88e2025-12-22Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.452092b4-7a8f-4d19-8113-f1c2a948d3d82025-12-05Warnings, Adverse reactionsName fallback
brand name: HYDROXYCHLOROQUINE SULFATE
generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEMajor Pharmaceuticalsebe00e35-ed3d-40f4-9a93-a37b0da01ddb2025-11-10Warnings, Adverse reactionsName fallback
brand name: HYDROXYCHLOROQUINE SULFATE
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEAphena Pharma Solutions - Tennessee, LLC427ac2fc-8f7f-9725-e063-6394a90a381b2025-10-31Warnings, Adverse reactionsName fallback
brand name: Hydroxychloroquine Sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATECreekwood Pharmaceuticals LLC04139607-f7c0-4fe1-a210-ffa5af347d562025-10-09Warnings, Adverse reactionsName fallback
brand name: HYDROXYCHLOROQUINE SULFATE
generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEZydus Lifesciences Limited1aa44bff-9a62-48b4-a520-98d7d524e3a92025-10-04Name fallback
brand name: Hydroxychloroquine sulfate
generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepackf95cfc03-5023-44b3-8994-25afac18b7342025-10-02Warnings, Adverse reactionsName fallback
brand name: HYDROXYCHLOROQUINE SULFATE
generic name: HYDROXYCHLOROQUINE SULFATE

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