Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 003444
Company: SS PHARMA
Company: SS PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DRISDOL | ERGOCALCIFEROL | 50,000 IU | CAPSULE;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 01/11/1941 | 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 |
|---|---|---|---|---|---|
| 11/20/2003 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/03444slr020ltr.pdf |
| 04/03/1992 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/14/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1988 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1986 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/11/1985 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/11/1985 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/07/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/19/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/07/1976 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/07/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 06/22/1976 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 03/04/1976 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/19/1975 | SUPPL-5 | Labeling |
Label is not available on this site. |
DRISDOL
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 |