Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Lactulose Solution USP, 10 g/15 mL, Novex Pharma ANDA 76-645 7/28/03 | Lactulose Solution USP, 10 g/15 mL, Novex Pharma ANDA 75-911 2/21/02 4/10/03 | Lactulose Solution, 10 g/5 mL, Vintage ANDA 75-993 LACTULOSE For Solution; 10GM/PACKET LACTULOSE INALCO | 074712 LACTULOSE For Solution; 20GM/PACKET LACTULOSE INALCO | 070288 LACTULOSE Solution; 10GM/15ML CONSTULOSE ALPHARMA | 071054 LACTULOSE Solution; 10GM/15ML CONSTILAC ALRA | 073497 LACTULOSE Solution; 10GM/15ML EVALOSE Copley | 074076 LACTULOSE Solution; 10GM/15ML LACTULOSE HI TECH 074602 LACTULOSE Solution; 10GM/15ML LACTULOSE Morton Grove | 075911 LACTULOSE Solution; 10GM/15ML LACTULOSE Novex | 074623 LACTULOSE Solution; 10GM/15ML LACTULOSE ASSOC | 073591 LACTULOSE Solution; 10GM/15ML LACTULOSE Roxane | 073686 LACTULOSE Solution; 10GM/15ML LAXILOSE TECHNILAB | 075993 LACTULOSE Solution; 10GM/15ML LACTULOSE Vintage | 074138 LACTULOSE Solution; 10GM/15ML LACTULOSE VISTAPHARM | 071548 LACTULOSE Solution; , Rectal 10GM/15ML ENULOSE ALPHARMA | 071331 LACTULOSE Solution; , Rectal 10GM/15ML CHOLAC ALRA | 073504 LACTULOSE Solution; , Rectal 10GM/15ML HEPTALAC Copley | 074077 LACTULOSE Solution; , Rectal 10GM/15ML LACTULOSE HI TECH 074603 LACTULOSE Solution; , Rectal 10GM/15ML GENERLAC Morton Grove | 076645 LACTULOSE Solution; , Rectal 10GM/15ML LACTULOSE Novex | 073685 LACTULOSE Solution; , Rectal 10GM/15ML ACILAC TECHNILAB | Lactulose Solution, ANI Pharma, Approval | Lactulose Oral or Rectal Solution, ANI Pharmaceuticals, Inc., Approval | Lactulose, lactulose, Solution; Oral, Rectal, Fresenius Kabi, Approval | Lactulose, lactulose, Solution; Oral, Fresenius Kabi, Approval ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com