Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018074
Company: VIRTUS PHARMS
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
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
03/22/2019 SUPPL-36 Labeling-Container/Carton Labels, Labeling-Package Insert 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/22/2019 SUPPL-36 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018074s036lbl.pdf
03/22/2019 SUPPL-36 Labeling-Package Insert 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English