An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 203340
Company: AZURITY

Summary Review

Products on NDA 203340

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NYMALIZE	NIMODIPINE	3MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;ORAL	Discontinued	None	Yes	No
NYMALIZE	NIMODIPINE	6MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203340

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/2013	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203340lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203340Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203340Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203340Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2020	SUPPL-13		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203340Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203340Orig1s013ltr.pdf
12/28/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203340s012lbl.pdf
04/09/2020	SUPPL-11	Manufacturing (CMC)-Formulation	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203340s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/203340Orig1s011.pdf
08/26/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/07/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/02/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203340

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2020	SUPPL-13	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203340Orig1s013lbl.pdf
04/09/2020	SUPPL-11	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203340s011lbl.pdf
12/28/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203340s012lbl.pdf
05/10/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203340lbl.pdf

Top