Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090426
Company: ANI PHARMS
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
11/21/2008 ORIG-1 Approval

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
ENULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription No AA 071548 ACTAVIS MID ATLANTIC
GENERLAC LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription No AA 074603 MORTON GROVE PHARMS
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription No AA 090426 ANI PHARMS
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription No AA 203762 BIO-PHARM INC
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription No AA 090502 FRESENIUS KABI
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription No AA 074077 HI TECH PHARMA

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