Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210757
Company: GRANULES
Company: GRANULES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
COLCHICINE | COLCHICINE | 0.6MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
04/29/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210757Orig1s000TAltr.pdf |
COLCHICINE
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 |