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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018708
Company: GALT PHARMS

Medication Guide

Other Important Information from FDA

Products on NDA 018708

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DORAL	QUAZEPAM	15MG	TABLET;ORAL	Prescription	None	Yes	Yes
DORAL	QUAZEPAM	7.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018708

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/1985	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018708Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2023	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018708s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018708Orig1s029ltr.pdf
02/05/2021	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018708s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018708Orig1s027ltr.pdf
02/06/2019	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018708s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018708Orig1s025ltr.pdf
12/16/2016	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018708s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018708Orig1s023ltr.pdf
04/19/2013	SUPPL-21	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf
04/19/2013	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf
04/13/2010	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018708s018lbl.pdf
10/30/2007	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018708s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018708s017ltr.pdf
11/14/2002	SUPPL-14	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18708slr014ltr.pdf
09/12/1996	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/03/1994	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/12/1993	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
07/11/1991	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/08/1991	SUPPL-7	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
08/05/1991	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/08/1991	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/26/1987	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
02/26/1987	SUPPL-2	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/26/1987	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 018708

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2023	SUPPL-29	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018708s029lbl.pdf
01/13/2023	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018708s029lbl.pdf
02/05/2021	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018708s027lbl.pdf
02/06/2019	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018708s025lbl.pdf
12/16/2016	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018708s023lbl.pdf
04/19/2013	SUPPL-21	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf
04/19/2013	SUPPL-20	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf
04/19/2013	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf
04/13/2010	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018708s018lbl.pdf
10/30/2007	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018708s017lbl.pdf

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