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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020648
Company: BAUSCH

Other Important Information from FDA

Products on NDA 020648

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIASTAT	DIAZEPAM	2.5MG/0.5ML (5MG/ML)	GEL;RECTAL	Prescription	None	Yes	Yes
DIASTAT	DIAZEPAM	5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;RECTAL	Discontinued	None	Yes	No
DIASTAT	DIAZEPAM	10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;RECTAL	Discontinued	None	Yes	No
DIASTAT	DIAZEPAM	15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;RECTAL	Discontinued	None	Yes	No
DIASTAT	DIAZEPAM	20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;RECTAL	Discontinued	None	Yes	No
DIASTAT ACUDIAL	DIAZEPAM	20MG/4ML (5MG/ML)	GEL;RECTAL	Prescription	AB	Yes	Yes
DIASTAT ACUDIAL	DIAZEPAM	10MG/2ML (5MG/ML)	GEL;RECTAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020648

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; 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
01/13/2023	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020648s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020648Orig1s023ltr.pdf
03/25/2021	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020648s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020648Orig1s022ltr.pdf
02/05/2021	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020648s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020648Orig1s021ltr.pdf
12/16/2016	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020648s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020648Orig1s014ltr.pdf
10/27/2016	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020648s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020648Orig1s013ltr.pdf
12/16/2014	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020648s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020648Orig1s012ltr.pdf
08/29/2013	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020648Orig1s009ltr.pdf
09/15/2005	SUPPL-8	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF) Patient Package Insert (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020648s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020648s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020648s008ppi.pdf
06/18/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/17/2000	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/31/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/11/2001	SUPPL-2	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20648S2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020648_S002_DIASTAT_AP.pdf
08/25/1998	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020648

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2023	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020648s023lbl.pdf
03/25/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020648s022lbl.pdf
02/05/2021	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020648s021lbl.pdf
12/16/2016	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020648s014lbl.pdf
12/16/2016	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020648s014lbl.pdf
10/27/2016	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020648s013lbl.pdf
12/16/2014	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020648s012lbl.pdf
09/15/2005	SUPPL-8	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020648s008lbl.pdf

Therapeutic Equivalents for NDA 020648

DIASTAT

There are no Therapeutic Equivalents.

DIASTAT ACUDIAL

GEL;RECTAL; 20MG/4ML (5MG/ML)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIASTAT ACUDIAL	DIAZEPAM	20MG/4ML (5MG/ML)	GEL;RECTAL	Prescription	Yes	AB	020648	BAUSCH
DIAZEPAM	DIAZEPAM	20MG/4ML (5MG/ML)	GEL;RECTAL	Prescription	No	AB	091076	NOVEL LABS INC

GEL;RECTAL; 10MG/2ML (5MG/ML)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIASTAT ACUDIAL	DIAZEPAM	10MG/2ML (5MG/ML)	GEL;RECTAL	Prescription	Yes	AB	020648	BAUSCH
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	GEL;RECTAL	Prescription	No	AB	091076	NOVEL LABS INC

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