Application 203851
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 1,000 UNITS/ML | No | No |
| 002 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/ML | No | No |
| 003 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0404-9873 | HEPARIN SODIUM | heparin sodium injection | Henry Schein, Inc. | ANDA | Current |
| 0404-9873 | HEPARIN SODIUM | heparin sodium injection | Henry Schein, Inc. | ANDA | Current |
| 0404-9873 | HEPARIN SODIUM | heparin sodium injection | Henry Schein, Inc. | ANDA | Current |
| 52584-116 | HEPARIN SODIUM | heparin sodium injection | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-116 | HEPARIN SODIUM | heparin sodium injection | General Injectables and Vaccines, Inc. | ANDA | Current |
| 67457-372 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-372 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-372 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-372 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-374 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-374 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-374 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-374 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-383 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-383 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-383 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-383 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-384 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-384 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-384 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-384 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-385 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-385 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-385 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-385 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-602 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-602 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-602 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-602 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-603 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-603 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-603 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-603 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-948 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-948 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-948 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-948 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-948 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-948 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-948 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-948 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-949 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-949 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-949 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-949 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-949 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-949 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-949 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-949 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-950 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-950 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-950 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-950 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-950 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-950 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-950 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-950 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-952 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-952 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-952 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-952 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-952 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-952 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-952 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-952 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-953 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-953 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-953 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-953 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-953 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-953 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-953 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-953 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-954 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-954 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-954 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-954 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-954 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-954 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-954 | Heparin Sodium | Heparin Sodium | Mylan Institutional LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 50578 | ORIG | 2017-12-01 |