Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085061
Company: CONTRACT PHARMACAL
Company: CONTRACT PHARMACAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FOLIC ACID | FOLIC ACID | 1MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/29/1976 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/085061.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/05/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |