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Abbreviated New Drug Application (ANDA): 212260
Company: NOVITIUM PHARMA
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
05/31/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212260Orig1s000ltr.pdf

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 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 PHARM INDS LTD
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
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