Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211638
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | 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 |
---|---|---|---|---|---|---|---|
03/23/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SILDENAFIL CITRATE
FOR SUSPENSION;ORAL; EQ 10MG BASE/ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
REVATIO | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 203109 | VIATRIS |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 212883 | AJANTA PHARMA LTD |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 212440 | ALKEM LABS LTD |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 211092 | AMNEAL PHARMS |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 213814 | APPCO |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 213041 | APTAPHARMA INC |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 214773 | AUROBINDO PHARMA LTD |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 214556 | GRANULES |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 213014 | HETERO LABS LTD V |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 211638 | LUPIN LTD |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 214641 | MSN |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 212260 | NOVITIUM PHARMA |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 215522 | TARO |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 211534 | TEVA PHARMS USA |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 215708 | ZYDUS LIFESCIENCES |