Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018385
Company: NOVO NORDISK INC
Company: NOVO NORDISK INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ULTRALENTE | INSULIN ZINC SUSP EXTENDED PURIFIED BEEF | 100 UNITS/ML | 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 |
---|---|---|---|---|---|---|---|
03/17/1980 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
09/17/1986 | SUPPL-9 | Labeling |
Label is not available on this site. |
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05/08/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |