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): 208564
Company: MAYNE PHARMA

Products on NDA 208564

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMVEXXY	ESTRADIOL	0.004MG	INSERT;VAGINAL	Prescription	AB	Yes	Yes
IMVEXXY	ESTRADIOL	0.01MG	INSERT;VAGINAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208564

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208564s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208564Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208564Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208564s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208564Orig1s006ltr.pdf
11/21/2019	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208564s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208564Orig1s003ltr.pdf
11/16/2021	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208564s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208564Orig1s002ltr.pdf

Labels for NDA 208564

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208564s006lbl.pdf
11/16/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208564s002lbl.pdf
11/21/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208564s003lbl.pdf
05/29/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208564s000lbl.pdf

Therapeutic Equivalents for NDA 208564

IMVEXXY

INSERT;VAGINAL; 0.004MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.004MG	INSERT;VAGINAL	Prescription	No	AB	214137	TEVA PHARMS USA INC
IMVEXXY	ESTRADIOL	0.004MG	INSERT;VAGINAL	Prescription	Yes	AB	208564	MAYNE PHARMA

INSERT;VAGINAL; 0.01MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.01MG	INSERT;VAGINAL	Prescription	No	AB	214137	TEVA PHARMS USA INC
IMVEXXY	ESTRADIOL	0.01MG	INSERT;VAGINAL	Prescription	Yes	AB	208564	MAYNE PHARMA

Top