Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050448
Company: JOHNSON AND JOHNSON
Company: JOHNSON AND JOHNSON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GRIFULVIN V | GRISEOFULVIN, MICROCRYSTALLINE | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/30/1972 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/08/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |