Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009830
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MESTINON | PYRIDOSTIGMINE BROMIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
10/02/1955 | 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 |
---|---|---|---|---|---|
12/07/1999 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/26/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
11/07/1996 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/26/2001 | SUPPL-10 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/09829s9lbl.pdf | |
10/27/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/12/1990 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/31/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/16/1983 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/08/1980 | SUPPL-4 | 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-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/09829s9lbl.pdf |
MESTINON
INJECTABLE;INJECTION; 5MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MESTINON | PYRIDOSTIGMINE BROMIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 009830 | BAUSCH |
REGONOL | PYRIDOSTIGMINE BROMIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 017398 | SANDOZ |