Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212702
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
01/10/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212702Orig1s000ltr.pdf |
PYRIDOSTIGMINE BROMIDE
SYRUP;ORAL; 60MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MESTINON | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | Yes | AA | 015193 | BAUSCH |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | No | AA | 212702 | AMNEAL |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | No | AA | 212405 | MILLA PHARMS |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | No | AA | 216512 | MSN |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | No | AA | 211694 | NOVITIUM PHARMA |
PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG/5ML | SYRUP;ORAL | Prescription | No | AA | 208797 | RISING |