FDA application holder
B Braun Medical Inc
The Orange Book identifies this organization as the applicant responsible for NDA 019531.
Orange Book drug · Brand (NDA)
Nutrilipid 10%
Soybean Oil
DiscontinuedRLDNDA 019531 B Braun
Approved
May 28, 1993
Strengths
1
Listed patents
0
What does the FDA Orange Book show for Nutrilipid 10%?
Nutrilipid 10% contains Soybean Oil and is the new drug FDA Orange Book record for NDA 019531. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.
- FDA application
- NDA 019531
- Application holder
- B Braun Medical Inc
- Product presentations
- 1
- Marketing categories
- Discontinued
- Reference roles
- RLD
- TE codes
- None posted
- Listed patents
- 0
- Exclusivity records
- 0
New drug application identity from the Orange Book snapshot.
The listed applicant holds the FDA application; this field does not establish the product manufacturer.
Each FDA product number remains tied to its own strength, dosage form, route, and status.
Orange Book marketing categories do not establish real-time inventory or commercial availability.
RLD and RS designations are presentation-specific, not inferred from the trade name.
Therapeutic-equivalence codes apply only within the matching Orange Book product heading.
A zero means none appear in this snapshot, not that no patent rights exist.
FDA exclusivity and listed patent protection are distinct regulatory concepts.
Sourced from the official FDA Orange Book data file · snapshot refreshed
FDA product-presentation matrix
Every product number in this exact application
| Product | Strength | Dosage form / route | Marketing status | TE code | Reference role |
|---|---|---|---|---|---|
| 001 | 10% | INJECTABLEINJECTION | Discontinued | None posted | RLD |
Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.
Who is responsible for this application?
Application holder is not the same as manufacturer
Manufacturer status
Not established by the Orange Book
A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.
Regulatory interpretation
What the record means, and what it does not
FDA marketing status
1 presentation listed as on the Discontinued Drug Product List
A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.
Therapeutic equivalence
No TE code is posted for this application
No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.
Patent & exclusivity record
No listed patents or exclusivity records
This means none appear for this application in the current Orange Book files. It is not a freedom-to-operate opinion and does not rule out unlisted patents, regulatory barriers, or product-specific rights.
Same-ingredient landscape
0 other ANDAs and 11 other NDAs found
0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.
Which products are meaningfully comparable?
Exact ingredient + dosage form + route cohorts
NDA 019531 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
Injectable · Injection
Soybean Oil
- Product rows
- 13
- Active applications
- 4
- Active with AB row
- 0
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue NDA-019531
No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.
Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.
Product detail
NDA 019531
RLDDiscontinued
- Strength
- 10%
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Discontinued
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
33 yr 8 mo ago
Today
Pharmaceutical detail
FDA product recordActive ingredient
SOYBEAN OIL
Strength
10%
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019531
Product number
001
Marketing status
Discontinued
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Listed patents
Orange Book patent fileNo patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Active-ingredient family
Brand + generics
This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1998Liposyn III 30%Brand (NDA)
NDA 020181 · Hospira
- 1996Intralipid 20%Brand (NDA)
NDA 020248 · Fresenius
- 1993Intralipid 30%Brand (NDA)
NDA 019942 · Fresenius
- 1984Liposyn III 20%Brand (NDA)
NDA 018970 · Hospira
- 1984Liposyn III 10%Brand (NDA)
NDA 018969 · Hospira
- 1983Soyacal 10%Brand (NDA)
NDA 018465 · Alpha Thera
- 1983Soyacal 20%Brand (NDA)
NDA 018786 · Alpha Thera
- 1983Travamulsion 20%Brand (NDA)
NDA 018758 · Baxter Hlthcare
- 1982Travamulsion 10%Brand (NDA)
NDA 018660 · Baxter Hlthcare
- —Intralipid 10%Brand (NDA)
NDA 017643 · Fresenius
- —Intralipid 20%Brand (NDA)
NDA 018449 · Fresenius
How to use this record responsibly
Scope, limitations, and primary sources
What to verify before making a decision
- The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
- RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
- Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
- Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
- The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.
Official FDA references
- Electronic Orange Book record
- Orange Book preface and TE-code policy
- FDA product, patent, and exclusivity data files
Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.
Nutrilipid 10%: frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.
Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 019531 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
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