Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091193
Company: EMERALD INTL LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACLOFEN BACLOFEN 0.05MG/ML INJECTABLE;INTRATHECAL Prescription AP No No
BACLOFEN BACLOFEN 0.5MG/ML INJECTABLE;INTRATHECAL Prescription AP No No
BACLOFEN BACLOFEN 2MG/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
05/03/2016 ORIG-1 Approval

Label is not available on this site.

BACLOFEN

INJECTABLE;INTRATHECAL; 0.05MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACLOFEN BACLOFEN 0.05MG/ML INJECTABLE;INTRATHECAL Prescription No AP 091193 EMERALD INTL LTD
GABLOFEN BACLOFEN 0.05MG/ML INJECTABLE;INTRATHECAL Prescription No AP 022462 PIRAMAL CRITICAL
LIORESAL BACLOFEN 0.05MG/ML INJECTABLE;INTRATHECAL Prescription Yes AP 020075 SAOL THERAPS RES LTD

INJECTABLE;INTRATHECAL; 0.5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACLOFEN BACLOFEN 0.5MG/ML INJECTABLE;INTRATHECAL Prescription No AP 091193 EMERALD INTL LTD
GABLOFEN BACLOFEN 0.5MG/ML INJECTABLE;INTRATHECAL Prescription No AP 022462 PIRAMAL CRITICAL
LIORESAL BACLOFEN 0.5MG/ML INJECTABLE;INTRATHECAL Prescription Yes AP 020075 SAOL THERAPS RES LTD

INJECTABLE;INTRATHECAL; 2MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACLOFEN BACLOFEN 2MG/ML INJECTABLE;INTRATHECAL Prescription No AP 091193 EMERALD INTL LTD
GABLOFEN BACLOFEN 2MG/ML INJECTABLE;INTRATHECAL Prescription No AP 022462 PIRAMAL CRITICAL
LIORESAL BACLOFEN 2MG/ML INJECTABLE;INTRATHECAL Prescription Yes AP 020075 SAOL THERAPS RES LTD

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