FDA application holder
Shire Development Inc
The Orange Book identifies this organization as the applicant responsible for NDA 012359.
Orange Book drug · Brand (NDA)
Salutensin-demi
Hydroflumethiazide; Reserpine
DiscontinuedNDA 012359 Shire
Approved
Prior to Jan 1, 1982
Strengths
1
Listed patents
0
What does the FDA Orange Book show for Salutensin-demi?
Salutensin-demi contains Hydroflumethiazide; Reserpine and is the new drug FDA Orange Book record for NDA 012359. 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 012359
- Application holder
- Shire Development Inc
- Product presentations
- 1
- Marketing categories
- Discontinued
- Reference roles
- None posted
- 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 |
|---|---|---|---|---|---|
| 004 | 25MG;0.125MG | TABLETORAL | Discontinued | None posted | None posted |
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
5 other ANDAs and 0 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 012359 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
Tablet · Oral
Hydroflumethiazide; Reserpine
- Product rows
- 7
- Active applications
- 0
- Active with AB row
- 0
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue NDA-012359
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 012359
Discontinued
- Strength
- 25MG;0.125MG
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Discontinued
Key dates
Approval, patents, exclusivityNo patent or exclusivity dates are listed for this product.
Pharmaceutical detail
FDA product recordActive ingredient
HYDROFLUMETHIAZIDE; RESERPINE
Strength
25MG;0.125MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 012359
Product number
004
Marketing status
Discontinued
Reference listed drug (RLD)
No
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 brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1985Reserpine And HydroflumethiazideGeneric (ANDA)
ANDA 088907 · Par Pharm
- 1985Reserpine And HydroflumethiazideGeneric (ANDA)
ANDA 088932 · Ivax Pharms
- 1983Hydroflumethiazide And ReserpineGeneric (ANDA)
ANDA 088195 · Usl Pharma
- 1983Hydroflumethiazide And ReserpineGeneric (ANDA)
ANDA 088127 · Watson Labs
- 1983Hydroflumethiazide And ReserpineGeneric (ANDA)
ANDA 088110 · Watson Labs
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.
Salutensin-demi: 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 012359 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
Related FDA reference tools
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