Application 208994
- Type
- ANDA
- Sponsor
- PHARMALUCENCE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TECHNETIUM TC99M MERTIATIDE KIT | TECHNETIUM TC-99M MERTIATIDE KIT | INJECTABLE;INJECTION | N/A | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45567-0655 | Kit for the Preparation of Technetium Tc99m Mertiatide | Betiatide | Pharmalucence, Inc. | ANDA | Current |
| 45567-0655 | Kit for the Preparation of Technetium Tc99m Mertiatide | Betiatide | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 45567-0655 | Kit for the Preparation of Technetium Tc99m Mertiatide | Betiatide | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 59594 | ORIG | 2019-08-06 |