Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075993
Company: LANNETT CO INC
Company: LANNETT CO 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 |
---|---|---|---|---|---|---|---|
07/26/2001 | ORIG-1 | Approval |
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 |
---|---|---|---|---|---|---|---|---|
CONSTILAC | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 071054 | ALRA |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 074076 | AKORN |
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 | 074138 | VISTAPHARM |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 074602 | WOCKHARDT BIO AG |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 075911 | XTTRIUM LABS INC |
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