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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074623
Company: PHARM ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL 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
07/30/1996 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
03/24/2020 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/24/2020 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/24/2020 SUPPL-10 Labeling-Package Insert

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
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 074076 AKORN
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 209517 CHARTWELL RX
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 090503 FRESENIUS KABI
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 075993 LANNETT CO INC
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 074623 PHARM ASSOC
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 074138 VISTAPHARM
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 074602 WOCKHARDT BIO AG
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 075911 XTTRIUM LABS INC
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