Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204276
Company: PURACAP PHARM LLC
Company: PURACAP PHARM LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERGOCALCIFEROL | 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 |
---|---|---|---|---|---|---|---|
12/07/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ERGOCALCIFEROL
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 |