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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020075
Company: AMNEAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIORESAL BACLOFEN 0.5MG/ML INJECTABLE;INTRATHECAL Prescription AP Yes Yes
LIORESAL BACLOFEN 2MG/ML INJECTABLE;INTRATHECAL Prescription AP Yes Yes
LIORESAL BACLOFEN 0.05MG/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
06/17/1992 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2021 SUPPL-38 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020075Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020075Orig1s038ltr.pdf
01/16/2019 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020075s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020075Orig1s037ltr.pdf
12/22/2016 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.
09/30/2016 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020075s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020075Orig1s032ltr.pdf
11/19/2014 SUPPL-31 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020075Orig1s031ltr.pdf
06/05/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
06/07/2016 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
11/19/2013 SUPPL-28 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020075Orig1s028ltr.pdf
09/05/2013 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
03/06/2013 SUPPL-26 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s026lbl.pdf
01/10/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
11/13/2011 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020075s024ltr.pdf
03/25/2011 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020075s021ltr.pdf
05/08/2003 SUPPL-20 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20075scp020ltr.pdf
01/17/2003 SUPPL-19 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20075scm019ltr.pdf
12/10/2002 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
11/21/2002 SUPPL-17 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20075scp017ltr.pdf
03/06/2002 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20075s14s16ltr.pdf
05/03/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
03/06/2002 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20075s14s16ltr.pdf
05/05/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
08/21/1998 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
08/21/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
06/23/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
03/03/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
11/07/1996 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.
06/14/1996 SUPPL-4 Efficacy-New Indication

Label is not available on this site.
05/20/1994 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/13/2021 SUPPL-38 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020075Orig1s038lbl.pdf
01/16/2019 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020075s037lbl.pdf
09/30/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020075s032lbl.pdf
11/19/2013 SUPPL-28 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s028lbl.pdf
03/06/2013 SUPPL-26 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s026lbl.pdf
11/13/2011 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s024lbl.pdf
03/25/2011 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s021lbl.pdf

LIORESAL

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 AMNEAL
BACLOFEN BACLOFEN 0.5MG/ML INJECTABLE;INTRATHECAL Prescription No AP 210048 MAIA PHARMS INC
BACLOFEN BACLOFEN 0.5MG/ML INJECTABLE;INTRATHECAL Prescription No AP 209592 MYLAN LABS LTD
BACLOFEN BACLOFEN 0.5MG/ML INJECTABLE;INTRATHECAL Prescription No AP 217324 RUBICON
GABLOFEN BACLOFEN 0.5MG/ML INJECTABLE;INTRATHECAL Prescription Yes AP 022462 PIRAMAL CRITICAL
LIORESAL BACLOFEN 0.5MG/ML INJECTABLE;INTRATHECAL Prescription Yes AP 020075 AMNEAL

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 AMNEAL
BACLOFEN BACLOFEN 2MG/ML INJECTABLE;INTRATHECAL Prescription No AP 210048 MAIA PHARMS INC
BACLOFEN BACLOFEN 2MG/ML INJECTABLE;INTRATHECAL Prescription No AP 209592 MYLAN LABS LTD
BACLOFEN BACLOFEN 2MG/ML INJECTABLE;INTRATHECAL Prescription No AP 217324 RUBICON
GABLOFEN BACLOFEN 2MG/ML INJECTABLE;INTRATHECAL Prescription Yes AP 022462 PIRAMAL CRITICAL
LIORESAL BACLOFEN 2MG/ML INJECTABLE;INTRATHECAL Prescription Yes AP 020075 AMNEAL

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 AMNEAL
BACLOFEN BACLOFEN 0.05MG/ML INJECTABLE;INTRATHECAL Prescription No AP 210777 MAIA PHARMS INC
GABLOFEN BACLOFEN 0.05MG/ML INJECTABLE;INTRATHECAL Prescription Yes AP 022462 PIRAMAL CRITICAL
LIORESAL BACLOFEN 0.05MG/ML INJECTABLE;INTRATHECAL Prescription Yes AP 020075 AMNEAL
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