Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062279
Company: VALEANT LUXEMBOURG
Company: VALEANT LUXEMBOURG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GRIFULVIN V | GRISEOFULVIN, MICROCRYSTALLINE | 125MG | TABLET;ORAL | Discontinued | None | No | No |
GRIFULVIN V | GRISEOFULVIN, MICROCRYSTALLINE | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
GRIFULVIN V | GRISEOFULVIN, MICROSIZE | 500MG | TABLET;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 |
---|---|---|---|---|---|---|---|
06/02/1980 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/22/2014 | SUPPL-22 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062279s022lbl.pdf | |
08/08/1997 | SUPPL-16 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/62483S013.pdf | |
02/16/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
01/27/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/27/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/22/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/02/1990 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/17/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/27/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/22/2014 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062279s022lbl.pdf |