Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078319
Company: ANTARES PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription AB No No
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS 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
12/10/2015 ORIG-1 Approval

Label is not available on this site.

SUMATRIPTAN SUCCINATE

INJECTABLE;SUBCUTANEOUS; EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX STATDOSE SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription Yes AB 020080 GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AB 078319 ANTARES PHARMA INC

INJECTABLE;SUBCUTANEOUS; EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX STATDOSE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription Yes AB 020080 GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AB 078319 ANTARES PHARMA INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AB 090495 DR REDDYS
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AB 090358 SUN PHARM

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