Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090502
Company: FRESENIUS KABI
Company: FRESENIUS KABI
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LACTULOSE | 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 |
---|---|---|---|---|---|---|---|
01/25/2012 | ORIG-1 | Approval |
Label is not available on this site. |
LACTULOSE
SOLUTION;ORAL, RECTAL; 10GM/15ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GENERLAC | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 074603 | WOCKHARDT BIO AG |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 076645 | BAJAJ |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 090502 | FRESENIUS KABI |