Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210577
Company: AMNEAL PHARMS CO
Company: AMNEAL PHARMS CO
| 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 |
|---|---|---|---|---|---|---|---|
| 05/15/2018 | ORIG-1 | Approval | STANDARD |
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 | 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 |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English