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. |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English