Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211519
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription AB No No
COLCHICINE COLCHICINE 0.3MG TABLET;ORAL Prescription None 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
02/19/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/15/2020 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/14/2019 SUPPL-1 Manufacturing (CMC)-New Strength Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211519Orig1s001ltr.pdf

COLCHICINE

TABLET;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 TABLET;ORAL Prescription No AB 211250 ALKEM LABS LTD
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 204711 AMNEAL PHARMS
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 209876 DR REDDYS
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 210425 GRANULES
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 208993 HETERO LABS LTD V
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 209470 MYLAN
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 203976 PAR PHARM INC
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 204461 WATSON LABS INC
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 211519 ZYDUS PHARMS
COLCRYS COLCHICINE 0.6MG TABLET;ORAL Prescription Yes AB 022352 TAKEDA PHARMS USA

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