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): 211285
Company: EUGIA PHARMA

Products on ANDA 211285

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROGESTERONE	PROGESTERONE	100MG	CAPSULE;ORAL	Prescription	AB	No	No
PROGESTERONE	PROGESTERONE	200MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211285

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211285

PROGESTERONE

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROGESTERONE	PROGESTERONE	100MG	CAPSULE;ORAL	Prescription	No	AB	207724	AMNEAL PHARMS NY
PROGESTERONE	PROGESTERONE	100MG	CAPSULE;ORAL	Prescription	No	AB	200900	BIONPHARMA
PROGESTERONE	PROGESTERONE	100MG	CAPSULE;ORAL	Prescription	No	AB	208801	DR REDDYS
PROGESTERONE	PROGESTERONE	100MG	CAPSULE;ORAL	Prescription	No	AB	211285	EUGIA PHARMA
PROGESTERONE	PROGESTERONE	100MG	CAPSULE;ORAL	Prescription	No	AB	200456	SOFGEN PHARMS
PROGESTERONE	PROGESTERONE	100MG	CAPSULE;ORAL	Prescription	No	AB	205229	XIROMED
PROMETRIUM	PROGESTERONE	100MG	CAPSULE;ORAL	Prescription	Yes	AB	019781	VIRTUS

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROGESTERONE	PROGESTERONE	200MG	CAPSULE;ORAL	Prescription	No	AB	207724	AMNEAL PHARMS NY
PROGESTERONE	PROGESTERONE	200MG	CAPSULE;ORAL	Prescription	No	AB	200900	BIONPHARMA
PROGESTERONE	PROGESTERONE	200MG	CAPSULE;ORAL	Prescription	No	AB	208801	DR REDDYS
PROGESTERONE	PROGESTERONE	200MG	CAPSULE;ORAL	Prescription	No	AB	211285	EUGIA PHARMA
PROGESTERONE	PROGESTERONE	200MG	CAPSULE;ORAL	Prescription	No	AB	200456	SOFGEN PHARMS
PROGESTERONE	PROGESTERONE	200MG	CAPSULE;ORAL	Prescription	No	AB	205229	XIROMED
PROMETRIUM	PROGESTERONE	200MG	CAPSULE;ORAL	Prescription	Yes	AB	019781	VIRTUS

Top