Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206336
Company: PAR PHARM INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM 1.1GM TABLET;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
09/08/2015 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206336Orig1s000ltr.pdf

BALSALAZIDE DISODIUM

TABLET;ORAL; 1.1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM 1.1GM TABLET;ORAL Prescription No AB 206336 PAR PHARM INC
GIAZO BALSALAZIDE DISODIUM 1.1GM TABLET;ORAL Prescription Yes AB 022205 VALEANT PHARMS INTL

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