Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077442
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PSEUDOEPHEDRINE HYDROCHLORIDE | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
09/28/2005 | ORIG-1 | Approval |
Label is not available on this site. |
PSEUDOEPHEDRINE HYDROCHLORIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, EXTENDED RELEASE;ORAL; 120MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
PSEUDOEPHEDRINE HYDROCHLORIDE | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 209008 | AUROBINDO PHARMA |
PSEUDOEPHEDRINE HYDROCHLORIDE | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 075153 | L PERRIGO CO |
PSEUDOEPHEDRINE HYDROCHLORIDE | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 077442 | SUN PHARM INDS LTD |