Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210959
Company: LAURUS
Company: LAURUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/15/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/01/2024 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
01/08/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
03/06/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
07/12/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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07/12/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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04/01/2020 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210959Orig1s001,s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210959Orig1s001,s005ltr.pdf | |
04/01/2020 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210959Orig1s001,s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210959Orig1s001,s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/01/2020 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210959Orig1s001,s005lbl.pdf | |
04/01/2020 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210959Orig1s001,s005lbl.pdf | |
04/01/2020 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210959Orig1s001,s005lbl.pdf |
HYDROXYCHLOROQUINE SULFATE
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 213342 | ACCORD HLTHCARE |
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 201691 | ALKALOIDA ZRT |
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 210577 | AMNEAL PHARMS CO |
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 210441 | APPCO |
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 040274 | AUROBINDO PHARMA USA |
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 210543 | CHARTWELL RX |
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 040150 | CREEKWOOD PHARMS |
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 040766 | IPCA LABS LTD |
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 210959 | LAURUS |
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 040104 | SANDOZ |
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 212902 | SENORES PHARMS |
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 040081 | TEVA PHARMS |
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 040657 | ZYDUS PHARMS USA INC |
PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 009768 | CONCORDIA |