Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074712
Company: CUMBERLAND PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LACTULOSE LACTULOSE 10GM/PACKET FOR SOLUTION;ORAL Prescription None No Yes
LACTULOSE LACTULOSE 20GM/PACKET FOR SOLUTION;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/10/1997 ORIG-1 Approval Review (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074712Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/14/2001 SUPPL-1 Manufacturing (CMC)-Facility

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