Drugs@FDA: FDA-Approved Drugs
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. |