Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040150
Company: ALLIED
Company: ALLIED
| 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 |
|---|---|---|---|---|---|---|---|
| 01/27/1996 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/01/2020 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040150Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040150Orig1s007ltr.pdf | |
| 03/20/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/2001 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/01/2020 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040150Orig1s007lbl.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 | 040150 | ALLIED |
| 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 | 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 |