Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080880
Company: IMPAX LABS
Company: IMPAX LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 250MG | 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 |
---|---|---|---|---|---|---|---|
12/11/1974 | 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 |
---|---|---|---|---|---|
02/02/2024 | SUPPL-69 | Labeling-Package Insert |
Label is not available on this site. |
||
07/24/2023 | SUPPL-68 | Labeling-Package Insert |
Label is not available on this site. |
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05/03/2022 | SUPPL-66 | Labeling-Package Insert |
Label is not available on this site. |
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03/17/2022 | SUPPL-65 | Labeling-Package Insert |
Label is not available on this site. |
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04/30/2020 | SUPPL-63 | Labeling-Package Insert |
Label is not available on this site. |
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07/18/1997 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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10/11/1996 | SUPPL-43 | Labeling |
Label is not available on this site. |
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12/15/1988 | SUPPL-40 | Labeling |
Label is not available on this site. |
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11/22/1988 | SUPPL-39 | Labeling |
Label is not available on this site. |
CHLOROQUINE PHOSPHATE
TABLET;ORAL; 250MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 250MG | TABLET;ORAL | Prescription | No | AA | 080880 | IMPAX LABS |
CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 250MG | TABLET;ORAL | Prescription | No | AA | 090610 | IPCA LABS LTD |
CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 250MG | TABLET;ORAL | Prescription | No | AA | 091621 | NATCO PHARMA LTD |