Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018708
Company: GALT PHARMS
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
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
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-Package Insert, Labeling-Medication Guide 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) 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
04/13/2010 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English