Application 011559
- Type
- NDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BREVITAL SODIUM | METHOHEXITAL SODIUM | INJECTABLE;INJECTION | 500MG/VIAL | Yes | Yes |
| 002 | BREVITAL SODIUM | METHOHEXITAL SODIUM | INJECTABLE;INJECTION | 2.5GM/VIAL | Yes | Yes |
| 003 | BREVITAL SODIUM | METHOHEXITAL SODIUM | INJECTABLE;INJECTION | 5GM/VIAL | No | No |
| 004 | BREVITAL SODIUM | METHOHEXITAL SODIUM | INJECTABLE;INJECTION | 200MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-105 | Brevital Sodium | methohexital sodium | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-105 | Brevital Sodium | methohexital sodium | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-105 | Brevital Sodium | methohexital sodium | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-105 | Brevital Sodium | methohexital sodium | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-105 | Brevital Sodium | methohexital sodium | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-106 | Brevital Sodium | methohexital sodium | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-106 | Brevital Sodium | methohexital sodium | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-106 | Brevital Sodium | methohexital sodium | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-106 | Brevital Sodium | methohexital sodium | Par Pharmaceutical, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65150 | SUPPL | 2020-11-04 |
| 65082 | SUPPL | 2020-10-30 |
| 48216 | SUPPL | 2017-05-02 |
| 48188 | SUPPL | 2017-05-02 |
| 33048 | SUPPL | 2014-01-28 |
| 272 | SUPPL | 2014-01-24 |
| 10766 | SUPPL | 2008-06-12 |
| 271 | SUPPL | 2008-05-08 |
| 11941 | SUPPL | 2004-06-01 |
| 10765 | SUPPL | 2004-06-01 |
| 11940 | SUPPL | 2004-05-28 |
| 11939 | SUPPL | 2001-07-13 |