Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074603
Company: WOCKHARDT BIO AG

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENERLAC 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
10/31/1996 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
11/26/2001 SUPPL-5 Labeling

Label is not available on this site.
04/05/2001 SUPPL-4 Labeling

Label is not available on this site.
07/15/1999 SUPPL-3 Labeling

Label is not available on this site.
04/14/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
04/14/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

GENERLAC

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 WOCKHARDT BIO AG
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription No AA 090426 ANI PHARMS
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
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL Prescription No AA 203762 TORRENT

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