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): 209547
Company: NOVAST LABS

Products on ANDA 209547

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MALMOREDE	ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE	0.05MG;1MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209547

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209547

MALMOREDE

TABLET;ORAL-28; 0.05MG;1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE	0.05MG;1MG	TABLET;ORAL-28	Prescription	No	AB	204704	MYLAN LABS LTD
MALMOREDE	ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE	0.05MG;1MG	TABLET;ORAL-28	Prescription	No	AB	209547	NOVAST LABS
ZOVIA 1/50E-28	ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE	0.05MG;1MG	TABLET;ORAL-28	Prescription	No	AB	072723	WATSON LABS

Top