Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206941
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | None | No | No |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | 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 |
---|---|---|---|---|---|---|---|
03/17/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
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; 60MG;1.2GM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 091070 | ACTAVIS LABS FL |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 209692 | AMNEAL PHARMS |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 206941 | AUROBINDO PHARMA |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 217340 | DR REDDYS |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 207602 | PERRIGO R AND D |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 214781 | SUN PHARM |
MUCINEX DM | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 021620 | 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; 30MG;600MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 091070 | ACTAVIS LABS FL |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 209692 | AMNEAL PHARMS |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 206941 | AUROBINDO PHARMA |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 217340 | DR REDDYS |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 207602 | PERRIGO R AND D |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 214781 | SUN PHARM |
MUCINEX DM | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 021620 | RB HLTH |