Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213479
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | 2MG | TABLET;ORAL | Prescription | AB | No | No |
LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | 3MG | TABLET;ORAL | Prescription | AB | No | Yes |
LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | 1MG | TABLET;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
07/01/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LEVORPHANOL TARTRATE
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | 2MG | TABLET;ORAL | Prescription | No | AB | 074278 | HIKMA |
LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | 2MG | TABLET;ORAL | Prescription | No | AB | 213479 | NOVITIUM PHARMA |
LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | 2MG | TABLET;ORAL | Prescription | No | AB | 212024 | SPECGX LLC |
LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | 2MG | TABLET;ORAL | Prescription | No | AB | 213906 | SUN PHARM INDS INC |
LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | 2MG | TABLET;ORAL | Prescription | No | AB | 211484 | VIRTUS |
TABLET;ORAL; 3MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | 3MG | TABLET;ORAL | Prescription | No | AB | 213479 | NOVITIUM PHARMA |
LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | 3MG | TABLET;ORAL | Prescription | No | AB | 213906 | SUN PHARM INDS INC |