FDA application holder
Viatris Specialty LLC
The Orange Book identifies this organization as the applicant responsible for NDA 008762.
Orange Book drug · Brand (NDA)
Dilantin-125
Phenytoin
RLDNDA 008762 Viatris
Approved
Prior to Jan 1, 1982
Strengths
1
Listed patents
0
What does the FDA Orange Book show for Dilantin-125?
Dilantin-125 contains Phenytoin and is the new drug FDA Orange Book record for NDA 008762. 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 008762
- Application holder
- Viatris Specialty LLC
- Product presentations
- 1
- Marketing categories
- Prescription
- Reference roles
- RLD / RS
- TE codes
- AB
- 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 | 125MG/5ML | SUSPENSIONORAL | Prescription | AB | RLDRS |
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 AB across rated presentations
An AB 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
8 other ANDAs and 0 other NDAs found
5 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 008762 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
Suspension · Oral
Phenytoin
- Product rows
- 7
- Active applications
- 2
- Active with AB row
- 2
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue NDA-008762
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 008762
TE ABRLDRS
- Strength
- 125MG/5ML
- Dosage form
- SUSPENSION
- Route
- ORAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityNo patent or exclusivity dates are listed for this product.
Pharmaceutical detail
FDA product recordActive ingredient
PHENYTOIN
Strength
125MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 008762
Product number
001
Marketing status
Prescription
Reference listed drug (RLD)
Yes
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.
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.
- 2014PhenytoinGeneric (ANDA)
ANDA 040884 · Epic Pharma LLC
- 2014PhenytoinGeneric (ANDA)
ANDA 200565 · Taro
- 2012PhenytoinGeneric (ANDA)
ANDA 200691 · Rising
- 2004PhenytoinGeneric (ANDA)
ANDA 040521 · Taro
- 2002PhenytoinGeneric (ANDA)
ANDA 040420 · Pai Holdings Pharm
- 2001PhenytoinGeneric (ANDA)
ANDA 040342 · Vistapharm LLC
- 1992PhenytoinGeneric (ANDA)
ANDA 089892 · Actavis Mid Atlantic
- —DilantinGeneric (ANDA)
ANDA 084427 · Pharmacia
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.
Dilantin-125: 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 008762 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
Related FDA reference tools
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
