Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040512
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG | TABLET;ORAL | Prescription | AB | No | No |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 30MG | TABLET;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 |
---|---|---|---|---|---|---|---|
10/08/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/040512.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/20/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
PYRIDOSTIGMINE BROMIDE
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 |