Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204841
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUMATRIPTAN SUMATRIPTAN 5MG/SPRAY SPRAY;NASAL Prescription AB No No
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
02/19/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2018 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/26/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

SUMATRIPTAN

SPRAY;NASAL; 5MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX SUMATRIPTAN 5MG/SPRAY SPRAY;NASAL Prescription Yes AB 020626 GLAXOSMITHKLINE
SUMATRIPTAN SUMATRIPTAN 5MG/SPRAY SPRAY;NASAL Prescription No AB 204841 LANNETT CO INC

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 204841 LANNETT CO INC

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