Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020698
Company: BRAINTREE
Company: BRAINTREE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIRALAX | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION; ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
02/18/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20698pi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20698ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020698.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/09/2004 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20698s009ltr.pdf |
03/13/2009 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
||
06/21/2001 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/05/2004 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20698scp004ltr.pdf |
06/20/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
08/18/2000 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/13/2009 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/18/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20698pi.pdf |