Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 018074
Company: VIRTUS

Products on NDA 018074

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018074

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/1979	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/13/2020	SUPPL-37		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018074Orig1s037lbl.pdf
03/22/2019	SUPPL-36	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018074s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018074Orig1s036ltr.pdf
02/10/2012	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018074s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018074s034ltr.pdf
11/08/1999	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
06/16/1999	SUPPL-29	Labeling		Label is not available on this site.
11/03/1998	SUPPL-28	Labeling		Label is not available on this site.
09/23/1998	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
02/02/1996	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
08/30/1995	SUPPL-25	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/17/1995	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
04/25/1994	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
04/25/1994	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
04/01/1985	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
05/03/1985	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
11/19/1982	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
09/10/1981	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
09/10/1981	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
03/23/1981	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/25/1981	SUPPL-15	Labeling		Label is not available on this site.
09/25/1980	SUPPL-14	Manufacturing (CMC)-Formulation		Label is not available on this site.
05/05/1981	SUPPL-13	Labeling		Label is not available on this site.
08/18/1980	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/28/1980	SUPPL-9	Labeling		Label is not available on this site.
02/01/1980	SUPPL-5	Labeling		Label is not available on this site.
11/26/1979	SUPPL-4	Labeling		Label is not available on this site.
10/26/1979	SUPPL-3	Manufacturing (CMC)-Formulation		Label is not available on this site.
10/15/1979	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
10/15/1979	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018074

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
11/13/2020	SUPPL-37	Manufacturing (CMC)	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018074Orig1s037lbl.pdf
03/22/2019	SUPPL-36	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018074s036lbl.pdf
03/22/2019	SUPPL-36	Labeling-Container/Carton Labels	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018074s036lbl.pdf
02/10/2012	SUPPL-34	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018074s034lbl.pdf