Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MESTINON | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | AA | Yes | 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 |
---|---|---|---|---|---|---|---|
01/25/1965 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
10/29/2019 | SUPPL-27 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/015193Orig1s027ltr.pdf |
02/23/2015 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/26/2013 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/30/2014 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/22/2002 | SUPPL-20 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/15193s020ltr.pdf |
11/07/1996 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/26/2001 | SUPPL-18 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf | |
10/27/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/17/1993 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/27/1986 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
02/04/1982 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/26/2001 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf |
MESTINON
SYRUP;ORAL; 60MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MESTINON | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | Yes | AA | 015193 | BAUSCH |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | No | AA | 212702 | AMNEAL |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | No | AA | 212405 | MILLA PHARMS |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | No | AA | 216512 | MSN |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | No | AA | 211694 | NOVITIUM PHARMA |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | No | AA | 208797 | RISING |