FDA application holder
Hikma Pharmaceuticals USA Inc
The Orange Book identifies this organization as the applicant responsible for ANDA 040056.
Orange Book drug · Generic (ANDA)
Leucovorin Calcium Preservative Free
Leucovorin Calcium
ANDA 040056 Hikma
Approved
May 23, 1995
Strengths
1
Listed patents
0
Applications
12
What does the FDA Orange Book show for Leucovorin Calcium Preservative Free?
Leucovorin Calcium Preservative Free contains Leucovorin Calcium and appears in 12 FDA Orange Book applications. ANDA 040056 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.
- FDA applications
- 12; lead ANDA 040056
- Lead application holder
- Hikma Pharmaceuticals USA Inc
- Product presentations
- 1
- Marketing categories
- Prescription
- Reference roles
- RS
- TE codes
- AP
- Listed patents
- 0
- Exclusivity records
- 0
Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.
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 | EQ 200MG BASE/VIAL | INJECTABLEINJECTION | Prescription | AP | RS |
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 prescription
RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.
Therapeutic equivalence
TE code AP across rated presentations
An AP code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.
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
39 other ANDAs and 4 other NDAs found
16 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
ANDA 040056 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
Leucovorin Calcium
- Product rows
- 42
- Active applications
- 13
- Active with AB row
- 0
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue ANDA-040056
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
ANDA 040056
TE APRS
- Strength
- EQ 200MG BASE/VIAL
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
31 yr 8 mo ago
Today
Pharmaceutical detail
FDA product recordActive ingredient
LEUCOVORIN CALCIUM
Strength
EQ 200MG BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 040056
Product number
001
Marketing status
Prescription
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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.
Other FDA applications for Leucovorin Calcium Preservative Free
11 additional filings · 11 generic
The FDA has approved 12 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.
| Application | Applicant | Approved | Strengths | TE code | Status |
|---|---|---|---|---|---|
| ANDA 040286 | Fresenius Kabi USA | Feb 26, 1999 | 1 | AP | Prescription |
| ANDA 040335 | Hikma | Apr 20, 2000 | 1 | AP | Prescription |
| ANDA 040147 | Hospira | Jun 25, 1997 | 2 | — | Discontinued |
| ANDA 040258 | Fresenius Kabi USA | Feb 26, 1999 | 1 | AP | Prescription |
| ANDA 040332 | Teva Parenteral | Jun 28, 1999 | 1 | — | Discontinued |
| ANDA 040338 | Am Regent | Jan 31, 2001 | 1 | — | Discontinued |
| ANDA 040347 | Hikma | Apr 25, 2000 | 2 | — | Discontinued |
| ANDA 200753 | Sagent Pharms | Sep 06, 2012 | 3 | AP | Prescription |
| ANDA 200855 | Sagent Pharms | Sep 06, 2012 | 1 | AP | Prescription |
| ANDA 203800 | Mylan Labs Ltd | May 19, 2017 | 3 | AP | Prescription |
| ANDA 209110 | Sagent Pharms Inc | Oct 26, 2017 | 1 | AP | Prescription |
Active-ingredient family
Brand + generics
Generic (ANDA) of Leucovorin Calcium
- 2026VykouraBrand (NDA)
NDA 220406 · Avyxa Holdings
- 1987Leucovorin CalciumBrand (NDA)
NDA 008107 · Hospira
- 1986Leucovorin CalciumBrand (NDA)
NDA 018459 · Xanodyne Pharm
- 1983WellcovorinBrand (NDA)
NDA 018342 · Glaxosmithkline
- 2025Leucovorin CalciumGeneric (ANDA)
ANDA 218200 · Gland
- 2023Leucovorin CalciumGeneric (ANDA)
ANDA 216590 · Meitheal
- 2023Leucovorin CalciumGeneric (ANDA)
ANDA 217021 · Hainan Poly
- 2020Leucovorin CalciumGeneric (ANDA)
ANDA 213929 · Leading
- 2020Leucovorin CalciumGeneric (ANDA)
ANDA 211132 · Ingenus Pharms LLC
- 2018Leucovorin CalciumGeneric (ANDA)
ANDA 210917 · Ingenus Pharms LLC
- 2018Leucovorin CalciumGeneric (ANDA)
ANDA 207226 · Fresenius Kabi USA
- 2018Leucovorin CalciumGeneric (ANDA)
ANDA 207241 · Fresenius Kabi USA
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.
Leucovorin Calcium Preservative Free: 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 ANDA 040056 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
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