Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217330
Company: ANNORA PHARMA
Company: ANNORA 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 | 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 |
|---|---|---|---|---|---|---|---|
| 08/17/2023 | 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 | 216400 | ALKEM LABS LTD |
| FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 216427 | AMNEAL |
| FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217330 | ANNORA PHARMA |
| FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 219091 | AUROBINDO PHARMA LTD |
| FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217137 | CARNEGIE |
| FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 219603 | CONTRACT PHARMACAL |
| FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 218344 | EPIC PHARMA LLC |
| FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217982 | LANNETT CO INC |
| 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 | 219863 | MSN |
| 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 | 201995 | NOVITIUM PHARMA |
| FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 215043 | NOVITIUM PHARMA |
| FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217655 | SOMERSET THERAPS LLC |
| FAMOTIDINE | FAMOTIDINE | 40MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217605 | UNICHEM |