Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 040502
Company: IMPAX LABS
Company: IMPAX LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 04/24/2003 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/28/2010 | 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 | 211181 | ELYSIUM |
| PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 040502 | IMPAX LABS |
| PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 205650 | ZYDUS PHARMS |
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