Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022462
Company: PIRAMAL CRITICAL

• Summary Review

Products on NDA 022462

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GABLOFEN	BACLOFEN	0.05MG/ML	INJECTABLE;INTRATHECAL	Prescription	AP	Yes	Yes
GABLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE;INTRATHECAL	Prescription	AP	Yes	Yes
GABLOFEN	BACLOFEN	2MG/ML	INJECTABLE;INTRATHECAL	Prescription	AP	Yes	Yes
GABLOFEN	BACLOFEN	1MG/ML	INJECTABLE;INTRATHECAL	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022462

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
05/31/2022	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022462Orig1s015Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022462Orig1s015ltr.pdf
04/19/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022462s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022462Orig1s013ltr.pdf
12/19/2019	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022462s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022462Orig1s011ltr.pdf
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.

Labels for NDA 022462

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2022	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022462Orig1s015Lbl.pdf
04/19/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022462s013lbl.pdf
12/19/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022462s011lbl.pdf
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

Therapeutic Equivalents for NDA 022462

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	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

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; 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
BACLOFEN	BACLOFEN	1MG/ML	INJECTABLE;INTRATHECAL	Prescription	No	AP	217324	RUBICON
GABLOFEN	BACLOFEN	1MG/ML	INJECTABLE;INTRATHECAL	Prescription	Yes	AP	022462	PIRAMAL CRITICAL