Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018969
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIPOSYN III 10% | SOYBEAN OIL | 10% | 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 |
---|---|---|---|---|---|---|---|
09/24/1984 | 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 |
---|---|---|---|---|---|
03/24/2003 | SUPPL-12 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18969scs012ltr.pdf |
11/17/1997 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/27/1996 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/16/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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11/02/1990 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/04/1988 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/22/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/06/1986 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |