Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216335
Company: ASPIRO
Company: ASPIRO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LACOSAMIDE | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
09/14/2022 | 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 |
---|---|---|---|---|---|
01/18/2023 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
LACOSAMIDE
SOLUTION;INTRAVENOUS; 200MG/20ML (10MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LACOSAMIDE | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216670 | APOTEX |
LACOSAMIDE | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216335 | ASPIRO |
LACOSAMIDE | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217718 | DR REDDYS |
LACOSAMIDE | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214677 | FRESENIUS KABI USA |
LACOSAMIDE | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215628 | GLAND PHARMA LTD |
LACOSAMIDE | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217311 | HAINAN POLY |
LACOSAMIDE | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216806 | HIKMA |
LACOSAMIDE | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214301 | INDOCO |
LACOSAMIDE | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215979 | MSN |
LACOSAMIDE | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209465 | ZYDUS PHARMS |
VIMPAT | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 022254 | UCB INC |