Drugs@FDA: FDA-Approved Drugs
Company: BIONPHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VITAMIN D | ERGOCALCIFEROL | 50,000 IU | CAPSULE;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 10/16/1978 | 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 |
|---|---|---|---|---|---|
| 07/24/2008 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 10/24/2001 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 10/24/2001 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/24/2001 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/24/2001 | SUPPL-38 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 10/24/2001 | SUPPL-37 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/09/1998 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1995 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1997 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1995 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 03/22/1985 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1985 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1985 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1985 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1985 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1985 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1984 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
VITAMIN D
CAPSULE;ORAL; 50,000 IU
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DRISDOL | ERGOCALCIFEROL | 50,000 IU | CAPSULE;ORAL | Prescription | Yes | AA | 003444 | SS PHARMA |
| ERGOCALCIFEROL | ERGOCALCIFEROL | 50,000 IU | CAPSULE;ORAL | Prescription | No | AA | 040833 | CHARTWELL RX |
| ERGOCALCIFEROL | ERGOCALCIFEROL | 50,000 IU | CAPSULE;ORAL | Prescription | No | AA | 204276 | PURACAP PHARM LLC |
| ERGOCALCIFEROL | ERGOCALCIFEROL | 50,000 IU | CAPSULE;ORAL | Prescription | No | AA | 090455 | STRIDES PHARMA |
| VITAMIN D | ERGOCALCIFEROL | 50,000 IU | CAPSULE;ORAL | Prescription | No | AA | 080704 | BIONPHARMA |