Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204820
Company: HIKMA INTL PHARMS
Company: HIKMA INTL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MITIGARE | COLCHICINE | 0.6MG | CAPSULE;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
09/26/2014 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204820s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204820Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204820Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204820Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/16/2024 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204820s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204820Orig1s006ltr.pdf | |
11/16/2018 | SUPPL-4 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204820Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204820Orig1s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/16/2024 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204820s006lbl.pdf | |
11/16/2018 | SUPPL-4 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204820Orig1s004lbl.pdf | |
09/26/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204820s000lbl.pdf |
MITIGARE
CAPSULE;ORAL; 0.6MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
COLCHICINE | COLCHICINE | 0.6MG | CAPSULE;ORAL | Prescription | No | AB | 217620 | ANNORA PHARMA |
COLCHICINE | COLCHICINE | 0.6MG | CAPSULE;ORAL | Prescription | No | AB | 215463 | AUROBINDO PHARMA LTD |
COLCHICINE | COLCHICINE | 0.6MG | CAPSULE;ORAL | Prescription | No | AB | 208678 | ENDO OPERATIONS |
COLCHICINE | COLCHICINE | 0.6MG | CAPSULE;ORAL | Prescription | No | AB | 210757 | GRANULES |
MITIGARE | COLCHICINE | 0.6MG | CAPSULE;ORAL | Prescription | Yes | AB | 204820 | HIKMA INTL PHARMS |