Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077807
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM 750MG 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
12/28/2007 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/077807_original_approval_pkg.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/23/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

BALSALAZIDE DISODIUM

CAPSULE;ORAL; 750MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM 750MG CAPSULE;ORAL Prescription No AB 077883 APOTEX INC
BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM 750MG CAPSULE;ORAL Prescription No AB 077807 MYLAN
BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM 750MG CAPSULE;ORAL Prescription No AB 077806 WEST-WARD PHARMS INT
COLAZAL BALSALAZIDE DISODIUM 750MG CAPSULE;ORAL Prescription Yes AB 020610 VALEANT PHARMS INTL

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