Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086008
Company: BIOGLAN
Company: BIOGLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALPHADERM | HYDROCORTISONE; UREA | 1%;10% | CREAM;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/20/1978 | 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 |
|---|---|---|---|---|---|
| 10/19/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/19/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/01/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/18/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |