Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210453
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | None | No | No |
GUAIFENESIN | GUAIFENESIN | 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 |
---|---|---|---|---|---|---|---|
10/21/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
GUAIFENESIN
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
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 207342 | AMNEAL PHARMS |
GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 210453 | AUROBINDO PHARMA |
GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 215932 | DR REDDYS |
GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 213420 | GRANULES |
GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 209215 | GUARDIAN DRUG |
GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 217780 | MARKSANS PHARMA |
GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 209254 | OHM LABS INC |
GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 078912 | PERRIGO R AND D |
MUCINEX | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 021282 | 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
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 091009 | ACTAVIS LABS FL |
GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 207342 | AMNEAL PHARMS |
GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 210453 | AUROBINDO PHARMA |
GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 215932 | DR REDDYS |
GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 213420 | GRANULES |
GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 209215 | GUARDIAN DRUG |
GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 217780 | MARKSANS PHARMA |
GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 209254 | OHM LABS INC |
GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 078912 | PERRIGO R AND D |
MUCINEX | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 021282 | RB HLTH |