Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212024
Company: SPECGX LLC
Company: SPECGX LLC
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/13/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/04/2021 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
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 |