Application 020298
- Type
- NDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ALOPRIM | ALLOPURINOL SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51662-1323 | GLUCAG0N | glucagon kit | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1323 | GLUCAG0N | glucagon kit | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1323 | GLUCAG0N | glucagon kit | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1323 | GLUCAG0N | glucagon kit | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 67457-187 | Aloprim | Allopurinol | Mylan Institutional LLC | NDA | Current |
| 67457-187 | Aloprim | Allopurinol | Mylan Institutional LLC | NDA | Current |
| 67457-187 | Aloprim | Allopurinol | Mylan Institutional LLC | NDA | Current |
| 67457-187 | Aloprim | Allopurinol | Mylan Institutional LLC | NDA | Current |
| 67457-187 | Aloprim | Allopurinol | Mylan Institutional LLC | NDA | Current |
| 67457-187 | Aloprim | Allopurinol | Mylan Institutional LLC | NDA | Current |
| 67457-978 | Aloprim | Allopurinol | Mylan Institutional LLC | NDA | Current |
| 67457-978 | Aloprim | Allopurinol | Mylan Institutional LLC | NDA | Current |
| 67457-978 | Aloprim | Allopurinol | Mylan Institutional LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79833 | SUPPL | 2024-10-07 |
| 70212 | SUPPL | 2022-02-22 |
| 70189 | SUPPL | 2022-02-18 |
| 65874 | SUPPL | 2021-01-08 |
| 65637 | SUPPL | 2020-12-21 |
| 64507 | SUPPL | 2020-09-04 |
| 64461 | SUPPL | 2020-09-01 |
| 12426 | SUPPL | 2016-04-04 |