Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021667
Company: EMMAUS MEDCL
Company: EMMAUS MEDCL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NUTRESTORE | L-GLUTAMINE | 5GM/PACKET | FOR SOLUTION;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
06/10/2004 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21677_nutreStore_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-667_NutreStroe.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/31/2021 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021667s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021667Orig1s007ltr.pdf | |
10/30/2014 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/14/2011 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021667s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021667s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/31/2021 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021667s007lbl.pdf | |
03/14/2011 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021667s003lbl.pdf | |
06/10/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21677_nutreStore_lbl.pdf |