Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 019786
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPRESSOR | METOPROLOL FUMARATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| LOPRESSOR | METOPROLOL FUMARATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| LOPRESSOR | METOPROLOL FUMARATE | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| LOPRESSOR | METOPROLOL FUMARATE | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/27/1989 | ORIG-1 | Approval | Type 2 - New Active Ingredient and Type 3 - New Dosage Form | STANDARD |
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