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 | TABLET;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 |
---|---|---|---|---|---|---|---|
04/06/1955 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
05/16/2014 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/09/2014 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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07/20/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/30/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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11/10/1997 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/07/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/26/2001 | SUPPL-11 | Labeling |
Label is not available on this site. |
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10/24/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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07/26/2001 | SUPPL-9 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf | |
01/27/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
02/18/1981 | SUPPL-5 | Manufacturing (CMC)-Formulation |
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-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf |
MESTINON
TABLET;ORAL; 60MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MESTINON | PYRIDOSTIGMINE BROMIDE | 60MG | TABLET;ORAL | Prescription | Yes | AB | 009829 | BAUSCH |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 040512 | ANI PHARMS |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 040502 | IMPAX LABS |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 211181 | MLV |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 205650 | ZYDUS PHARMS |