Application 020843

Type: NDA
Sponsor: VIRTUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETRIUM	PROGESTERONE	CAPSULE; ORAL	100MG	No	No
002	PROMETRIUM	PROGESTERONE	CAPSULE; ORAL	200MG	No	No
003	PROMETRIUM	PROGESTERONE	CAPSULE; ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Progesterone	PROGESTERONE	Asclemed USA, Inc.	fd6b9861-04fc-42d8-90c8-021a69fe93e9	2023-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	A-S Medication Solutions	5e0263c5-2cb6-4e02-b883-2c05492a6260	2023-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone Combo	PROGESTERONE	Nutritional Specialties, Inc.	5ccf7bee-2da4-4347-8753-30680d7c1c03	2023-04-27	Warnings	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Asclemed USA, Inc.	19716042-8025-43a3-b26d-e0fd7d2587eb	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Asclemed USA, Inc.	efd6a8d8-c023-4d9f-b574-b14dc945203d	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Asclemed USA, Inc.	4a741977-1dbb-41e7-a560-9ac02936f8b1	2022-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Proficient Rx LP	e1546b35-cfa8-4808-9652-db1ba675a4e3	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Proficient Rx LP	73e65b35-2266-48a3-98f8-521446a55c22	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Bionpharma Inc.	3acad9b0-7ec6-4d5e-9852-32ffadbbed6d	2018-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
35497	SUPPL	2011-11-04
26031	SUPPL	2011-11-03
3547	SUPPL	2009-07-07
35496	SUPPL	2009-07-06
41757	ORIG	2005-06-16
26029	SUPPL	2004-12-10
26028	SUPPL	2004-12-10
13589	SUPPL	2004-12-10
13588	SUPPL	2004-12-10
26030	SUPPL	2004-03-10
35495	ORIG	1998-12-16
26027	ORIG	1998-12-16