Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074076
Company: HI TECH PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription AA 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
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-6 Labeling

Label is not available on this site.

05/14/2009 SUPPL-5 Labeling

Label is not available on this site.

10/08/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/08/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/08/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

LACTULOSE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CONSTILAC LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 071054 ALRA
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 078430 ANI PHARMS
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 090503 FRESENIUS KABI
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 074076 HI TECH PHARMA
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 074602 MORTON GROVE
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 074623 PHARM ASSOC
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 075993 VINTAGE PHARMS
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 074138 VISTAPHARM
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 073591 WEST-WARD PHARMS INT

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