Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073591
Company: WEST-WARD PHARMS INT
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
05/29/1992 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
02/06/2008 SUPPL-19 Labeling

Label is not available on this site.

10/23/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/2000 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/02/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/27/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/11/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/11/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/20/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/20/1996 SUPPL-7 Labeling

Label is not available on this site.

09/20/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/18/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-3 Labeling

Label is not available on this site.

08/18/1995 SUPPL-2 Labeling

Label is not available on this site.

08/18/1995 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 075993 LANNETT CO INC
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 209517 LIFEPHARMA
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 074623 PHARM ASSOC
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 207786 TORRENT
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
LACTULOSE LACTULOSE 10GM/15ML SOLUTION;ORAL Prescription No AA 074602 WOCKHARDT BIO AG

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