Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 016785
Company: LEADIANT BIOSCI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MATULANE PROCARBAZINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;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
07/22/1969 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/02/2016 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/20/2002 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16785slr035ltr.pdf
03/13/2002 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/13/2001 SUPPL-33 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/02/2001 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1999 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1998 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1987 SUPPL-29 Labeling

Label is not available on this site.

05/07/1986 SUPPL-28 Labeling

Label is not available on this site.

03/05/1987 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/17/1987 SUPPL-26 Labeling

Label is not available on this site.

04/29/1986 SUPPL-24 Labeling

Label is not available on this site.

12/18/1981 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/31/1981 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/24/1980 SUPPL-21 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/14/1979 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/11/1981 SUPPL-19 Labeling

Label is not available on this site.

03/24/1980 SUPPL-18 Labeling

Label is not available on this site.

01/09/1979 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1977 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1976 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

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