Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 040133
Company: WATSON LABS
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 11/30/1995 | 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 |
|---|---|---|---|---|---|
| 11/21/2003 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/19/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1997 | 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 | 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 | 040760 | HIKMA 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 LABS LTD |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 040274 | MYLAN |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 040104 | SANDOZ |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 040081 | TEVA PHARMS |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 210441 | TWI PHARMS |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET;ORAL | Prescription | No | AB | 040133 | WATSON LABS |
| 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 |
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