Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212542
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | None | No | No |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;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 |
---|---|---|---|---|---|---|---|
04/28/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
GUAIFENESIN AND 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; 600MG;60MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 091071 | ACTAVIS LABS FL |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 213203 | AUROBINDO PHARMA LTD |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 208369 | DR REDDYS |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 214407 | L PERRIGO CO |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 212542 | SUN PHARM INDS INC |
MUCINEX D | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 021585 | RB HLTH |
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; 1.2GM;120MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 091071 | ACTAVIS LABS FL |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 213203 | AUROBINDO PHARMA LTD |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 208369 | DR REDDYS |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 214407 | L PERRIGO CO |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 212542 | SUN PHARM INDS INC |
MUCINEX D | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 021585 | RB HLTH |