Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 019531
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NUTRILIPID 10% | SOYBEAN OIL | 10% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| NUTRILIPID 20% | SOYBEAN OIL | 20% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/28/1993 | 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 |
|---|---|---|---|---|---|
| 12/02/2015 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/2014 | SUPPL-2 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019531s002lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/12/2014 | SUPPL-2 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019531s002lbl.pdf |
NUTRILIPID 10%
INJECTABLE;INJECTION; 10%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INTRALIPID 10% | SOYBEAN OIL | 10% | INJECTABLE;INJECTION | Prescription | Yes | AP | 017643 | FRESENIUS |
| NUTRILIPID 10% | SOYBEAN OIL | 10% | INJECTABLE;INJECTION | Prescription | Yes | AP | 019531 | B BRAUN |
NUTRILIPID 20%
INJECTABLE;INJECTION; 20%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INTRALIPID 20% | SOYBEAN OIL | 20% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018449 | FRESENIUS |
| INTRALIPID 20% | SOYBEAN OIL | 20% | INJECTABLE;INJECTION | Prescription | Yes | AP | 020248 | FRESENIUS |
| NUTRILIPID 20% | SOYBEAN OIL | 20% | INJECTABLE;INJECTION | Prescription | Yes | AP | 019531 | B BRAUN |
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