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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213806
Company: EMCURE PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE;INJECTION Prescription AP 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
01/07/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

PENTAMIDINE ISETHIONATE

INJECTABLE;INJECTION; 300MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PENTAM PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 019264 FRESENIUS KABI USA
PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE;INJECTION Prescription No AP 213806 EMCURE PHARMS LTD
PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE;INJECTION Prescription No AP 206666 SETON PHARMS
PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE;INJECTION Prescription No AP 206982 XGEN PHARMS
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