Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214209
Company: CIPLA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUMATRIPTAN SUMATRIPTAN 20MG/SPRAY SPRAY;NASAL 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
02/22/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

SUMATRIPTAN

SPRAY;NASAL; 20MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX SUMATRIPTAN 20MG/SPRAY SPRAY;NASAL Prescription Yes AB 020626 GLAXOSMITHKLINE
SUMATRIPTAN SUMATRIPTAN 20MG/SPRAY SPRAY;NASAL Prescription No AB 214209 CIPLA
SUMATRIPTAN SUMATRIPTAN 20MG/SPRAY SPRAY;NASAL Prescription No AB 208967 FLORIDA
SUMATRIPTAN SUMATRIPTAN 20MG/SPRAY SPRAY;NASAL Prescription No AB 204841 LANNETT CO INC
SUMATRIPTAN SUMATRIPTAN 20MG/SPRAY SPRAY;NASAL Prescription No AB 213465 PERRIGO UK FINCO

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