Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210315
Company: MAIA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACLOFEN BACLOFEN 1MG/ML INJECTABLE;INTRATHECAL 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
07/30/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

BACLOFEN

INJECTABLE;INTRATHECAL; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACLOFEN BACLOFEN 1MG/ML INJECTABLE;INTRATHECAL Prescription No AP 210315 MAIA PHARMS INC
BACLOFEN BACLOFEN 1MG/ML INJECTABLE;INTRATHECAL Prescription No AP 209594 MYLAN LABS LTD
GABLOFEN BACLOFEN 1MG/ML INJECTABLE;INTRATHECAL Prescription Yes AP 022462 PIRAMAL CRITICAL

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