Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075911
Company: XTTRIUM LABS INC
Company: XTTRIUM LABS INC
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 |
---|---|---|---|---|---|---|---|
02/21/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75911APD.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/17/2024 | SUPPL-12 | Labeling-Package Insert |
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 |
---|---|---|---|---|---|---|---|---|
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 207786 | APOZEAL PHARMS |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 074602 | AUROBINDO PHARMA LTD |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 209517 | CHARTWELL RX |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 090503 | FRESENIUS KABI |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 075993 | LANNETT CO INC |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 074623 | PHARM ASSOC |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 075911 | XTTRIUM LABS INC |