Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090249
Company: IPCA LABS LTD
Company: IPCA LABS 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 | 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 |
---|---|---|---|---|---|---|---|
12/03/2009 | 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-8 | Labeling-Package Insert |
Label is not available on this site. |
||
05/03/2022 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
03/17/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
03/24/2020 | SUPPL-4 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/090249Orig1s003,s004ltr.pdf |
03/24/2020 | SUPPL-3 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/090249Orig1s003,s004ltr.pdf |
08/28/2015 | SUPPL-2 | 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 |