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

Abbreviated New Drug Application (ANDA): 218031
Company: NOVAST LABS

Products on ANDA 218031

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DROSPIRENONE AND ESTRADIOL	DROSPIRENONE; ESTRADIOL	0.5MG;1MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218031

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2025	ORIG-2	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218031Orig2s000TAltr.pdf
10/28/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218031

DROSPIRENONE AND ESTRADIOL

TABLET;ORAL; 0.5MG;1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANGELIQ	DROSPIRENONE; ESTRADIOL	0.5MG;1MG	TABLET;ORAL	Prescription	Yes	AB	021355	BAYER HLTHCARE
DROSPIRENONE AND ESTRADIOL	DROSPIRENONE; ESTRADIOL	0.5MG;1MG	TABLET;ORAL	Prescription	No	AB	218031	NOVAST LABS

Top