Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074077
Company: AKORN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription AA 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
07/03/1995 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/04/2009 SUPPL-7 Labeling

Label is not available on this site.
05/05/2009 SUPPL-5 Labeling

Label is not available on this site.
10/09/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
10/09/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
10/09/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

LACTULOSE

SOLUTION;ORAL, RECTAL; 10GM/15ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHOLAC LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription No AA 071331 ALRA
GENERLAC LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription No AA 074603 WOCKHARDT BIO AG
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription No AA 074077 AKORN
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription No AA 090502 FRESENIUS KABI

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