Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074712
Company: CUMBERLAND PHARMS
Company: CUMBERLAND PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LACTULOSE | LACTULOSE | 10GM/PACKET | FOR SOLUTION;ORAL | Prescription | None | No | Yes |
LACTULOSE | LACTULOSE | 20GM/PACKET | FOR SOLUTION;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
12/10/1997 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074712Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/14/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |