Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MESTINON | PYRIDOSTIGMINE BROMIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
01/12/1959 | 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 |
---|---|---|---|---|---|
07/25/2014 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/03/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/14/2001 | SUPPL-18 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
02/13/2001 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/07/1996 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/26/2001 | SUPPL-15 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf | |
10/24/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/26/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
07/18/1989 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/27/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
11/22/1978 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
02/16/1978 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/09/1977 | SUPPL-5 | Manufacturing (CMC)-Control |
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-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf |
MESTINON
TABLET, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MESTINON | PYRIDOSTIGMINE BROMIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 011665 | BAUSCH |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204737 | ALVOGEN |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203184 | IMPAX LABS INC |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205464 | RISING PHARMA |