Application 209382
- Type
- ANDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TREPROSTINIL | TREPROSTINIL | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 1MG/ML | No | No |
| 002 | TREPROSTINIL | TREPROSTINIL | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 2.5MG/ML | No | No |
| 003 | TREPROSTINIL | TREPROSTINIL | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 5MG/ML | No | No |
| 004 | TREPROSTINIL | TREPROSTINIL | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 10MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-206 | Treprostinil | Treprostinil | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-206 | Treprostinil | Treprostinil | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-207 | Treprostinil | Treprostinil | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-207 | Treprostinil | Treprostinil | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-208 | Treprostinil | Treprostinil | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-208 | Treprostinil | Treprostinil | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-209 | Treprostinil | Treprostinil | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-209 | Treprostinil | Treprostinil | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57321 | ORIG | 2019-01-22 |