Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080600
Company: HIKMA PHARMS
Company: HIKMA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 03/31/1972 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080600.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/17/2000 | SUPPL-31 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/13/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1999 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1997 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 12/10/1997 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1995 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 07/29/1994 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 07/29/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/17/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/01/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1984 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |