Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204782
Company: PERRIGO R AND D
Company: PERRIGO R AND D
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE;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 |
---|---|---|---|---|---|---|---|
08/29/2016 | ORIG-1 | Approval |
Label is not available on this site. |
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, CHEWABLE;ORAL; 800MG;10MG;165MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 077355 | PERRIGO R AND D |
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 204782 | PERRIGO R AND D |
PEPCID COMPLETE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE;ORAL | Over-the-counter | Yes | 020958 | J AND J CONSUMER INC |
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