Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071548
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL, RECTAL 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
08/15/1988 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
12/20/2009 SUPPL-38 Labeling

Label is not available on this site.

08/07/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/19/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/09/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/03/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/11/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/11/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/08/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/06/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/31/1990 SUPPL-13 Labeling

Label is not available on this site.

10/16/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/15/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

ENULOSE

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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