Application 040657

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

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
A040657-001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040657-001AB

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 UTC2026-02A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-213f01610625f2…
2019-09-15 20:21 UTC2019-09A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21cb3db0bc1861…

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 UTC2026-02A040657-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040657-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040657-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040657-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040657-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040657-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040657-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040657-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040657-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040657-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040657-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040657-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040657-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040657-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040657-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040657-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040657-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040657-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040657-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040657-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040657-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040657-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040657-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040657-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040657-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040657-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040657-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040657-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040657-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040657-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040657-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040657-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040657-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040657-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040657-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040657-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040657-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040657-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040657-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040657-001AB1cb3db0bc1861…

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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATECardinal Health 107, LLC6971241c-8323-456e-91a4-a404a9e100de2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
ndc (product): 55154-2074
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEPreferred Pharmaceuticals, Inc.d6c8ee2e-116e-4167-8d1a-bd570a1ce6722026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
ndc (product): 68788-7747
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATENuCare Pharmaceuticals, Inc.4902343c-7d1b-ba70-e063-6294a90a36802026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEZydus Lifesciences Limited1aa44bff-9a62-48b4-a520-98d7d524e3a92025-10-04Exact identifier
application applno (ANDA): 040657
application number: ANDA040657
ndc (product): 65841-633
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATENuCare Pharmaceuticals,Inc.b8e3a352-a1e3-e672-e053-2a95a90a641c2025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
ndc (product): 68071-2332
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions6a06ad3d-2d6c-4e51-93f5-8f782b86975b2025-05-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
ndc (product): 50090-5573
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions3817387f-2fc8-4f39-8096-3b48fff57ab02024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions53553ef5-5f44-4d39-ae8c-c9a632cc84162024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEAsclemed USA, Inc.19816051-c25e-44b5-a127-e846dbd0a8d82024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEAmerican Health Packaginga2d7be5a-98ee-4292-8715-46573dbe1c5b2024-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
ndc (product): 68084-269
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepackf618a091-ade1-4c39-ab76-f6218b606e052024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
ndc (product): 71335-0897
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATENCS HealthCare of KY, LLC dba Vangard Labs83cb17e9-ce57-48aa-b92c-ac0dee92d5bc2024-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions1a1fb21d-a01c-4d50-8764-cdd6c20d95692024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATENorthstar Rx LLC.29ba0172-7ca3-4122-af1b-f0da522318cb2023-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
ndc (product): 16714-110
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEQuallent Pharmaceuticals Health LLC81e68f23-b1bf-4561-8f02-a472631acfaf2023-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
ndc (product): 82009-045
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEZydus Pharmaceuticals USA Inc.805a1acd-2e0d-48f1-af6b-0e5d8e06c2282023-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
ndc (product): 68382-096
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEAphena Pharma Solutions - Tennessee, LLC90111c26-cd12-4a45-a25f-8d83c83c80de2020-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
ndc (product): 71610-506

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-110Hydroxychloroquine sulfateHydroxychloroquine sulfateNorthstar Rx LLC.ANDACurrent
16714-110Hydroxychloroquine sulfateHydroxychloroquine sulfateNorthstar Rx LLC.ANDACurrent
16714-110Hydroxychloroquine sulfateHydroxychloroquine sulfateNorthstar Rx LLC.ANDACurrent
16714-110Hydroxychloroquine sulfateHydroxychloroquine sulfateNorthstar Rx LLC.ANDACurrent
50090-5573Hydroxychloroquine sulfateHydroxychloroquine sulfateA-S Medication SolutionsANDACurrent
55154-2074Hydroxychloroquine sulfateHydroxychloroquine sulfateCardinal Health 107, LLCANDACurrent
55154-2074Hydroxychloroquine sulfateHydroxychloroquine sulfateCardinal HealthANDACurrent
55154-2074Hydroxychloroquine sulfateHydroxychloroquine sulfateCardinal HealthANDACurrent
55154-2074Hydroxychloroquine sulfateHydroxychloroquine sulfateCardinal HealthANDACurrent
61919-132HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDIRECT RXANDACurrent
63739-777Hydroxychloroquine sulfateHydroxychloroquine sulfateMcKesson CorporationANDACurrent
63739-777Hydroxychloroquine sulfateHydroxychloroquine sulfateMcKesson Corporation dba SKY PackagingANDACurrent
63739-777Hydroxychloroquine sulfateHydroxychloroquine sulfateMcKesson Corporation dba SKY PackagingANDACurrent
63739-777Hydroxychloroquine sulfateHydroxychloroquine sulfateMcKesson Corporation dba SKY PackagingANDACurrent
65841-633Hydroxychloroquine sulfateHydroxychloroquine sulfateCadila Healthcare LimitedANDACurrent
65841-633Hydroxychloroquine sulfateHydroxychloroquine sulfateCadila Healthcare LimitedANDACurrent
65841-633Hydroxychloroquine sulfateHydroxychloroquine sulfateZydus Lifesciences LimitedANDACurrent
65841-633Hydroxychloroquine sulfateHydroxychloroquine sulfateCadila Healthcare LimitedANDACurrent
68071-2332Hydroxychloroquine sulfateHydroxychloroquine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2912Hydroxychloroquine sulfateHydroxychloroquine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4648Hydroxychloroquine sulfateHydroxychloroquine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4648Hydroxychloroquine sulfateHydroxychloroquine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4648Hydroxychloroquine sulfateHydroxychloroquine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4648Hydroxychloroquine sulfateHydroxychloroquine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68084-269Hydroxychloroquine SulfateHydroxychloroquine SulfateAmerican Health PackagingANDACurrent
68084-269Hydroxychloroquine SulfateHydroxychloroquine SulfateAmerican Health PackagingANDACurrent
68084-269Hydroxychloroquine SulfateHydroxychloroquine SulfateAmerican Health PackagingANDACurrent
68084-269Hydroxychloroquine SulfateHydroxychloroquine SulfateAmerican Health PackagingANDACurrent
68382-096Hydroxychloroquine sulfateHydroxychloroquine sulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-096Hydroxychloroquine sulfateHydroxychloroquine sulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-096Hydroxychloroquine sulfateHydroxychloroquine sulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-096Hydroxychloroquine sulfateHydroxychloroquine sulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-7747Hydroxychloroquine sulfateHydroxychloroquine sulfatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7747Hydroxychloroquine sulfateHydroxychloroquine sulfatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7747Hydroxychloroquine sulfateHydroxychloroquine sulfatePreferred Pharmaceuticals, Inc.ANDACurrent
71335-0897Hydroxychloroquine sulfateHydroxychloroquine sulfateBryant Ranch PrepackANDACurrent
71335-0897Hydroxychloroquine sulfateHydroxychloroquine sulfateBryant Ranch PrepackANDACurrent
71335-0897Hydroxychloroquine sulfateHydroxychloroquine sulfateBryant Ranch PrepackANDACurrent
71335-0897Hydroxychloroquine sulfateHydroxychloroquine sulfateBryant Ranch PrepackANDACurrent
71610-506Hydroxychloroquine sulfateHydroxychloroquine sulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent
82009-045Hydroxychloroquine sulfateHydroxychloroquine sulfateQuallent Pharmaceuticals Health LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62478SUPPL2020-04-08
62477SUPPL2020-04-08