Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215043
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/20/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FAMOTIDINE
FOR SUSPENSION;ORAL; 40MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217529 | AJANTA PHARMA LTD |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 201995 | AKORN |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 216400 | ALKEM LABS LTD |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 216427 | AMNEALS PHARMS |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217330 | ANNORA PHARMA |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217137 | CARNEGIE |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 218344 | EPIC PHARMA LLC |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 090440 | LUPIN LTD |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217842 | MICRO LABS |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 091020 | NAVINTA LLC |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 201695 | NOVEL LABS INC |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 215043 | NOVITIUM PHARMA |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217605 | UNICHEM |
FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217655 | UPSHER SMITH LABS |