Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090612
Company: NATCO PHARMA LTD
Company: NATCO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 500MG | TABLET;ORAL | Prescription | AA | No | 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 |
---|---|---|---|---|---|---|---|
01/21/2011 | 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 |
---|---|---|---|---|---|
07/24/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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05/03/2022 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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03/17/2022 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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03/17/2022 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
CHLOROQUINE PHOSPHATE
TABLET;ORAL; 500MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 500MG | TABLET;ORAL | Prescription | No | AA | 040516 | IMPAX LABS |
CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 500MG | TABLET;ORAL | Prescription | No | AA | 090249 | IPCA LABS LTD |
CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 500MG | TABLET;ORAL | Prescription | No | AA | 090612 | NATCO PHARMA LTD |
CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 500MG | TABLET;ORAL | Prescription | No | AA | 214756 | SUVEN PHARMS |