Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074138
Company: VISTAPHARM
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
09/30/1992 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
11/28/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

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

Label is not available on this site.

12/22/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/22/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/24/1998 SUPPL-9 Labeling

Label is not available on this site.

01/31/1997 SUPPL-8 Labeling

Label is not available on this site.

01/31/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/20/1996 SUPPL-6 Labeling

Label is not available on this site.

08/07/1996 SUPPL-5 Labeling

Label is not available on this site.

08/07/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/07/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/22/1994 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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