Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202229
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACAMPROSATE CALCIUM | ACAMPROSATE CALCIUM | 333MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/16/2013 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202229Orig1s000ltr.pdf |
ACAMPROSATE CALCIUM
TABLET, DELAYED RELEASE;ORAL; 333MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACAMPROSATE CALCIUM | ACAMPROSATE CALCIUM | 333MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202229 | GLENMARK PHARMS LTD |
ACAMPROSATE CALCIUM | ACAMPROSATE CALCIUM | 333MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 200142 | MYLAN |
ACAMPROSATE CALCIUM | ACAMPROSATE CALCIUM | 333MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 205995 | ZYDUS PHARMS |