Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040081
Company: TEVA PHARMS
Company: TEVA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 09/30/1994 | 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 |
|---|---|---|---|---|---|
| 04/15/2024 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2023 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/08/2022 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2020 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/20/2008 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 02/05/2003 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/08/2002 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/08/2002 | SUPPL-13 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 10/08/2002 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/08/2002 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/23/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/26/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/10/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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 |