Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084088
Company: LANNETT
Company: LANNETT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VELTANE | BROMPHENIRAMINE MALEATE | 4MG | Tablet; 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 |
---|---|---|---|---|---|---|---|
05/17/1974 | ORIG-1 | Approval |
Label is not available on this site. |
VELTANE
Tablet; Oral; 4MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BROMPHENIRAMINE MALEATE | BROMPHENIRAMINE MALEATE | 4MG | Tablet; Oral | Prescription | No | AA | 085592 | NYLOS |
BROMPHENIRAMINE MALEATE | BROMPHENIRAMINE MALEATE | 4MG | Tablet; Oral | Prescription | No | AA | 085521 | PHOENIX LABS NY |
VELTANE | BROMPHENIRAMINE MALEATE | 4MG | Tablet; Oral | Prescription | No | AA | 084088 | LANNETT |