Application 050108
- Type
- NDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | COLY-MYCIN M | COLISTIMETHATE SODIUM | INJECTABLE;INJECTION | EQ 150MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-107 | Coly-Mycin | colistimethate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-107 | Coly-Mycin | colistimethate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-131 | Colistimethate | colistimethate sodium | Par Pharmaceutical, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82753 | SUPPL | 2025-07-08 |
| 82742 | SUPPL | 2025-07-08 |
| 48057 | SUPPL | 2017-04-18 |
| 48051 | SUPPL | 2017-04-18 |
| 29980 | SUPPL | 2013-03-08 |
| 17800 | SUPPL | 2013-03-08 |
| 17799 | SUPPL | 2009-06-07 |
| 7693 | SUPPL | 2009-05-19 |
| 44199 | ORIG | 2007-06-29 |
| 7692 | SUPPL | 2006-01-20 |
| 38913 | SUPPL | 2006-01-13 |
| 29979 | SUPPL | 2004-06-01 |