Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005897
Company: WYETH PHARMS INC
Company: WYETH PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FOLVITE | FOLIC ACID | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| FOLVITE | FOLIC ACID | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/05/1947 | 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 |
|---|---|---|---|---|---|
| 09/10/1984 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1984 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/1984 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/09/1981 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 10/26/1979 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1979 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/1979 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1979 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 01/10/1979 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/10/1979 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1979 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1976 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1976 | SUPPL-12 | Unspecified |
Label is not available on this site. |
||
| 05/13/1976 | SUPPL-11 | Unspecified |
Label is not available on this site. |