Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020256
Company: LANTHEUS MEDCL
Company: LANTHEUS MEDCL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEUROLITE | TECHNETIUM TC-99M BICISATE KIT | N/A | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/23/1994 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/03/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/24/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1996 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1997 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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