Application 016785
- Type
- NDA
- Sponsor
- LEADIANT BIOSCI INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MATULANE | PROCARBAZINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54482-053 | Matulane | procarbazine hydrochloride | Sigma-Tau Pharmaceuticals, Inc. | NDA | Current |
| 54482-053 | Matulane | procarbazine hydrochloride | Sigma-Tau Pharmaceuticals, Inc. | NDA | Current |
| 54482-054 | Matulane | procarbazine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-054 | Matulane | procarbazine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-054 | Matulane | procarbazine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-054 | Matulane | procarbazine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-054 | Matulane | procarbazine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-054 | Matulane | procarbazine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 13030 | SUPPL | 2003-01-29 |