FDA application holder
Pai Holdings LLC Dba Pharmaceutical Associates Inc And Dba Pai Pharma
The Orange Book identifies this organization as the applicant responsible for ANDA 040649.
Orange Book drug · Generic (ANDA)
Promethazine Dm
Dextromethorphan Hydrobromide; Promethazine Hydrochloride
ANDA 040649 Pai Holdings
Approved
Feb 14, 2006
Strengths
1
Listed patents
0
What does the FDA Orange Book show for Promethazine Dm?
Promethazine Dm contains Dextromethorphan Hydrobromide; Promethazine Hydrochloride and is the generic drug FDA Orange Book record for ANDA 040649. 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
- ANDA 040649
- Application holder
- Pai Holdings LLC Dba Pharmaceutical Associates Inc And Dba Pai Pharma
- Product presentations
- 1
- Marketing categories
- Prescription
- Reference roles
- RS
- TE codes
- AA
- Listed patents
- 0
- Exclusivity records
- 0
Abbreviated 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 | 15MG/5ML;6.25MG/5ML | SYRUPORAL | Prescription | AA | 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 AA across rated presentations
An AA 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
7 other ANDAs and 1 other NDA found
4 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 040649 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
Syrup · Oral
Dextromethorphan Hydrobromide; Promethazine Hydrochloride
- Product rows
- 9
- Active applications
- 6
- Active with AB row
- 0
Promethazine Hydrochloride And Dextromethorphan Hydrobromide · NDA 011265Promethazine Hydrochloride And Dextromethorphan Hydrobromide · ANDA 218264Promethazine Hydrochloride And Dextromethorphan Hydrobromide · ANDA 091687Promethazine Hydrochloride And Dextromethorphan Hydrobromide · ANDA 090575Promethazine Hydrochloride And Dextromethorphan Hydrobromide · ANDA 040027Pherazine Dm · ANDA 088913
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue ANDA-040649
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 040649
TE AARS
- Strength
- 15MG/5ML;6.25MG/5ML
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
20 yr 9 mo ago
Today
Pharmaceutical detail
FDA product recordActive ingredient
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Strength
15MG/5ML;6.25MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
AA
Application
ANDA 040649
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.
Active-ingredient family
Brand + generics
Generic (ANDA) of Dextromethorphan Hydrobromide; Promethazine Hydrochloride
- 1984Promethazine Hydrochloride And Dextromethorphan HydrobromideBrand (NDA)
NDA 011265 · Ani Pharms
- 2026Promethazine Hydrochloride And Dextromethorphan HydrobromideGeneric (ANDA)
ANDA 218264 · Hetero Labs Ltd III
- 2012Promethazine Hydrochloride And Dextromethorphan HydrobromideGeneric (ANDA)
ANDA 091687 · Cosette Pharms Nc
- 2011Promethazine Hydrochloride And Dextromethorphan HydrobromideGeneric (ANDA)
ANDA 090575 · Amneal Pharms
- 1996Promethazine Hydrochloride And Dextromethorphan HydrobromideGeneric (ANDA)
ANDA 040027 · Hikma
- 1987Pherazine DmGeneric (ANDA)
ANDA 088913 · Halsey
- 1985Promethazine W/ DextromethorphanGeneric (ANDA)
ANDA 088864 · Pharmobedient
- 1984Prometh W/ DextromethorphanGeneric (ANDA)
ANDA 088762 · G And W Labs Inc
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.
Promethazine Dm: 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 040649 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
