Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205650
Company: ZYDUS PHARMS
Company: ZYDUS 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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/22/2015 | ORIG-1 | Approval | STANDARD |
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 |