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Application 021388
- Type
- NDA
- Sponsor
- LYMOL MEDCL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TALC | TALC | POWDER;INTRAPLEURAL | 5GM/BOT | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63256-200 | Sterile Talc | Talc | Bryan Corporation | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 36808 | SUPPL | 2014-06-17 |
| 5238 | SUPPL | 2014-06-17 |
| 42134 | ORIG | 2004-05-06 |
| 5237 | ORIG | 2003-12-19 |
| 36807 | ORIG | 2003-12-17 |