Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202065
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL 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
06/12/2019 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202065Orig1s000TAltr.pdf

MESALAMINE

SUPPOSITORY;RECTAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CANASA MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription Yes AB 021252 ALLERGAN
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription No AB 205654 ACTAVIS MID ATLANTIC
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription No AB 210509 AMNEAL
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription No AB 208362 AMRING PHARMS
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription No AB 213377 ANNORA PHARMA
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription No AB 204354 MYLAN
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription No AB 207448 PHARM SOURCING
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription No AB 202065 SANDOZ INC
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription No AB 208953 ZYDUS PHARMS

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