Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022462
Company: PIRAMAL CRITICAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GABLOFEN BACLOFEN 0.05MG/ML INJECTABLE;INTRATHECAL Prescription AP No No
GABLOFEN BACLOFEN 0.5MG/ML INJECTABLE;INTRATHECAL Prescription AP No No
GABLOFEN BACLOFEN 2MG/ML INJECTABLE;INTRATHECAL Prescription AP No No
GABLOFEN BACLOFEN 1MG/ML INJECTABLE;INTRATHECAL Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/19/2010 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022462s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022462s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022462Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022462Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/11/2015 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022462s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022462Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022462Orig1s008.pdf
01/17/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/22/2012 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/11/2015 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022462s008lbl.pdf
11/19/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022462s000lbl.pdf

GABLOFEN

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
BACLOFEN BACLOFEN 0.5MG/ML INJECTABLE;INTRATHECAL Prescription No AP 209592 MYLAN LABS 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
BACLOFEN BACLOFEN 2MG/ML INJECTABLE;INTRATHECAL Prescription No AP 209592 MYLAN LABS 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

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 209594 MYLAN LABS LTD
GABLOFEN BACLOFEN 1MG/ML INJECTABLE;INTRATHECAL Prescription Yes AP 022462 PIRAMAL CRITICAL

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