Application 018074

Type: NDA
Sponsor: VIRTUS PHARMS

Related Records

Company: VIRTUS PHARMS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	105MG	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-5254	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Eon Labs, Inc.	NDA	Current
12634-910	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Apotheca Inc.	NDA	Current
17224-831	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	CALVIN, SCOTT AND COMPANY, INCORPORATED	NDA	Current
33261-390	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Aidarex Pharmaceuticals LLC	NDA	Current
43063-892	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-892	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-892	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-892	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-892	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-892	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
50090-0338	Phendimetrazine Tartrate	Phendimetrazine Tartrate	A-S Medication Solutions	NDA	Current
50090-3988	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	A-S Medication Solutions	NDA	Current
50090-3988	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	A-S Medication Solutions	NDA	Current
50090-3988	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	A-S Medication Solutions	NDA	Current
52959-886	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	H.J. Harkins Company, Inc.	NDA	Current
63629-3051	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Bryant Ranch Prepack	NDA	Current
63629-3051	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Bryant Ranch Prepack	NDA	Current
68071-3040	Phendimetrazine Tartrate	Phendimetrazine Tartrate	NuCare Pharmaceuticals, Inc.	NDA	Current
68071-3040	Phendimetrazine Tartrate	Phendimetrazine Tartrate	NuCare Pharmaceuticals, Inc.	NDA	Current
69543-409	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Virtus Pharmaceuticals, LLC	NDA	Current
69543-409	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Virtus Pharmaceuticals, LLC	NDA	Current
69543-409	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Virtus Pharmaceuticals, LLC	NDA	Current
69543-409	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Virtus Pharmaceuticals, LLC	NDA	Current
69543-413	FENDIQUE ER	PHENDIMETRAZINE TARTRATE	Virtus Pharmaceuticals, LLC	NDA	Current
69543-413	FENDIQUE ER	PHENDIMETRAZINE TARTRATE	Virtus Pharmaceuticals, LLC	NDA	Current
72989-409	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Acertis Pharmaceuticals, LLC	NDA	Current

Documents

Document	Submission type	Date
67015	SUPPL	2021-04-09
58077	SUPPL	2019-03-26
58072	SUPPL	2019-03-25
33411	SUPPL	2012-02-24
819	SUPPL	2012-02-14