Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214672
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LACOSAMIDE | LACOSAMIDE | 10MG/ML | 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 |
---|---|---|---|---|---|---|---|
05/19/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214672Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/28/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
LACOSAMIDE
SOLUTION;ORAL; 10MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 214672 | ALKEM LABS LTD |
LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 206355 | APOTEX |
LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 209224 | AUROBINDO PHARMA LTD |
LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 215154 | CHARTWELL RX |
LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 209301 | HETERO LABS LTD III |
LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 216461 | MEDLEY PHARMS |
LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 215379 | MSN |
LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 216151 | NOVITIUM PHARMA |
VIMPAT | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 022255 | UCB INC |