Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009768
Company: CONCORDIA
Company: CONCORDIA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/18/1955 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 07/24/2023 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009768s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/009768Orig1s060ltr.pdf | |
| 05/03/2022 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/009768s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/009768Orig1s056ltr.pdf | |
| 12/12/2023 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009768s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/009768Orig1s054ltr.pdf | |
| 05/03/2021 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/009768s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/009768Orig1s053ltr.pdf | |
| 01/05/2019 | SUPPL-51 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009768Orig1s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/009768Orig1s051ltr.pdf | |
| 01/27/2017 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009768Orig1s037,s045,s047ltr.pdf | |
| 01/27/2017 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009768Orig1s037,s045,s047ltr.pdf | |
| 06/20/2007 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009768s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009768s041ltr.pdf | |
| 01/27/2017 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009768Orig1s037,s045,s047ltr.pdf | |
| 05/02/2002 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/2002 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/2000 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 10/02/1996 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1994 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 02/14/1991 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1991 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/19/1990 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/04/1989 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1988 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/1988 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/12/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1985 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/1985 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/03/1987 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/01/1984 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/17/1983 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/15/1982 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1982 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/14/1982 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/02/1987 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/15/1981 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/19/1980 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/29/1976 | SUPPL-7 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/12/2023 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009768s054lbl.pdf | |
| 07/24/2023 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009768s060lbl.pdf | |
| 05/03/2022 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/009768s056lbl.pdf | |
| 05/03/2021 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/009768s053lbl.pdf | |
| 01/05/2019 | SUPPL-51 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009768Orig1s051lbl.pdf | |
| 01/05/2019 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009768Orig1s051lbl.pdf | |
| 01/27/2017 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf | |
| 01/27/2017 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf | |
| 01/27/2017 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf | |
| 06/20/2007 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009768s041lbl.pdf |
PLAQUENIL
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 |