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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022544
Company: ALMATICA

Medication Guide

Summary Review

Products on NDA 022544

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GRALISE	GABAPENTIN	300MG	TABLET;ORAL	Prescription	AB2	Yes	Yes
GRALISE	GABAPENTIN	600MG	TABLET;ORAL	Prescription	AB2	Yes	No
GRALISE	GABAPENTIN	450MG	TABLET;ORAL	Prescription	None	Yes	No
GRALISE	GABAPENTIN	750MG	TABLET;ORAL	Prescription	None	Yes	No
GRALISE	GABAPENTIN	900MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022544

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2011	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022544_gralise_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022544Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2023	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022544Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022544Orig1s029ltr.pdf
09/16/2021	SUPPL-27	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022544Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022544Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/022544Orig1s027.pdf
04/02/2020	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022544s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022544Orig1s026ltr.pdf
03/06/2017	SUPPL-24	Labeling-Container/Carton Labels		Label is not available on this site.
01/09/2017	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
09/09/2013	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/10/2013	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
07/31/2013	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/09/2013	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
03/28/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/13/2013	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
03/25/2013	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
01/31/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/27/2013	SUPPL-12	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022544s012lbl.pdf
11/30/2012	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/08/2012	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022544Orig1s008ltr.pdf
01/31/2012	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022544s006ltr.pdf
04/28/2011	SUPPL-3	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s003ltr.pdf
06/28/2011	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s002ltr.pdf

Labels for NDA 022544

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2023	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022544Orig1s029lbl.pdf
09/16/2021	SUPPL-27	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022544Orig1s027lbl.pdf
04/02/2020	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022544s026lbl.pdf
03/27/2013	SUPPL-12	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022544s012lbl.pdf
08/08/2012	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s008lbl.pdf
01/31/2012	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s006lbl.pdf
06/28/2011	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s002lbl.pdf
01/28/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s000lbl.pdf

Therapeutic Equivalents for NDA 022544

GRALISE

TABLET;ORAL; 300MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	300MG	TABLET;ORAL	Prescription	No	AB2	218075	ANNORA PHARMA
GABAPENTIN	GABAPENTIN	300MG	TABLET;ORAL	Prescription	No	AB2	216252	HUMANWELL
GABAPENTIN	GABAPENTIN	300MG	TABLET;ORAL	Prescription	No	AB2	203934	ZYDUS PHARMS
GRALISE	GABAPENTIN	300MG	TABLET;ORAL	Prescription	Yes	AB2	022544	ALMATICA

TABLET;ORAL; 600MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB2	218075	ANNORA PHARMA
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB2	216252	HUMANWELL
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB2	203934	ZYDUS PHARMS
GRALISE	GABAPENTIN	600MG	TABLET;ORAL	Prescription	Yes	AB2	022544	ALMATICA

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