Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076645
Company: BAJAJ
Company: BAJAJ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | 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 |
---|---|---|---|---|---|---|---|
07/28/2003 | 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 |
---|---|---|---|---|---|
02/20/2024 | SUPPL-7 | Labeling-Package Insert |
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 | CHARTWELL RX |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 203762 | APOZEAL PHARMS |
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 |