Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006170
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYPROTIGEN 5% | PROTEIN HYDROLYSATE | 5% | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 04/23/1947 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/10/1984 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/1984 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/10/1984 | SUPPL-4 | Efficacy |
Label is not available on this site. |
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