Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216030
Company: ASCENT PHARMS INC
Company: ASCENT PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | None | No | No |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;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 |
---|---|---|---|---|---|---|---|
11/03/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FAMOTIDINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 20MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 215766 | ANNORA PHARMA |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 216030 | ASCENT PHARMS INC |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 206531 | AUROBINDO PHARMA |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 218003 | CONTRACT PHARMACAL |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 077367 | DR REDDYS LABS LTD |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 090837 | GLENMARK PHARMS INC |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 218461 | GRAVITI PHARMS |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 217543 | MARKSANS PHARMA |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 077351 | PERRIGO R AND D |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 215822 | VKT PHARMA |
PEPCID AC | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | Yes | 020325 | J AND J CONSUMER INC |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 10MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 215766 | ANNORA PHARMA |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 216030 | ASCENT PHARMS INC |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 206531 | AUROBINDO PHARMA |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 218003 | CONTRACT PHARMACAL |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 077367 | DR REDDYS LABS LTD |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 077146 | GLENMARK PHARMS INC |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 218461 | GRAVITI PHARMS |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 217543 | MARKSANS PHARMA |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 075512 | P AND L |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 075400 | PERRIGO |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 215822 | VKT PHARMA |
PEPCID AC | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | Yes | 020325 | J AND J CONSUMER INC |
PEPCID AC | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 020902 | J AND J CONSUMER INC |