FDA application holder
Hikma Pharmaceuticals USA Inc
The Orange Book identifies this organization as the applicant responsible for ANDA 084612.
Orange Book drug · Generic (ANDA)
Dexamethasone
Dexamethasone
RLDANDA 084612 7 strengths Hikma
Approved
Prior to Jan 1, 1982
Strengths
7
Listed patents
0
Applications
49
What does the FDA Orange Book show for Dexamethasone?
Dexamethasone contains Dexamethasone and appears in 49 FDA Orange Book applications. ANDA 084612 is the lead filing, with 7 presentations 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
- 49; lead ANDA 084612
- Lead application holder
- Hikma Pharmaceuticals USA Inc
- Product presentations
- 7
- Marketing categories
- Prescription
- Reference roles
- RLD / RS
- TE codes
- AB
- 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 | 4MG | TABLETORAL | Prescription | AB | RLD |
| 002 | 0.5MG | TABLETORAL | Prescription | AB | RLD |
| 003 | 0.75MG | TABLETORAL | Prescription | AB | RLD |
| 004 | 1MG | TABLETORAL | Prescription | AB | RLDRS |
| 005 | 1.5MG | TABLETORAL | Prescription | AB | RLD |
| 006 | 2MG | TABLETORAL | Prescription | AB | RLDRS |
| 007 | 6MG | TABLETORAL | 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
7 presentations 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
6 other ANDAs and 11 other NDAs found
1 of the related ANDA application is 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 084612 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
Dexamethasone
- Product rows
- 87
- Active applications
- 17
- Active with AB row
- 15
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue ANDA-084612
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.
Strengths & dosage forms
7 approved presentations · ANDA 084612
TE ABRLD
- Strength
- 4MG
- Dosage form
- TABLET
- 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
DEXAMETHASONE
Strength
4MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 084612
Product number
001
Marketing status
Prescription
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.
TE ABRLD
- Strength
- 0.5MG
- Dosage form
- TABLET
- 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
DEXAMETHASONE
Strength
0.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 084612
Product number
002
Marketing status
Prescription
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.
TE ABRLD
- Strength
- 0.75MG
- Dosage form
- TABLET
- 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
DEXAMETHASONE
Strength
0.75MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 084612
Product number
003
Marketing status
Prescription
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.
TE ABRLDRS
- Strength
- 1MG
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
43 yr 6 mo ago
Today
Pharmaceutical detail
FDA product recordActive ingredient
DEXAMETHASONE
Strength
1MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 084612
Product number
004
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.
TE ABRLD
- Strength
- 1.5MG
- Dosage form
- TABLET
- 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
DEXAMETHASONE
Strength
1.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 084612
Product number
005
Marketing status
Prescription
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.
TE ABRLDRS
- Strength
- 2MG
- Dosage form
- TABLET
- 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
DEXAMETHASONE
Strength
2MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 084612
Product number
006
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.
TE ABRLDRS
- Strength
- 6MG
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
43 yr 6 mo ago
Today
Pharmaceutical detail
FDA product recordActive ingredient
DEXAMETHASONE
Strength
6MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 084612
Product number
007
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.
Other FDA applications for Dexamethasone
48 additional filings · 48 generic
The FDA has approved 49 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 084754 | Kanchan Hlthcare | Approved Prior to Jan 1, 1982 | 1 | AA | Prescription |
| ANDA 088248 | Hikma | Sep 01, 1983 | 1 | — | Prescription |
| ANDA 088254 | Pharmobedient Cnsltg | Jul 27, 1983 | 1 | — | Discontinued |
| ANDA 040700 | Bausch | Aug 15, 2008 | 1 | — | Discontinued |
| ANDA 080399 | Prasco | Approved Prior to Jan 1, 1982 | 2 | — | Discontinued |
| ANDA 080968 | Watson Labs | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 083420 | Pvt Form | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 083806 | Phoenix Labs Ny | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 084013 | Sun Pharm Industries | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 084081 | Sun Pharm Industries | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 084084 | Sun Pharm Industries | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 084086 | Sun Pharm Industries | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 084327 | Whiteworth Town Plsn | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 084457 | Watson Labs | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 084614 | Roxane | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 084763 | Sun Pharm Industries | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 084764 | Sun Pharm Industries | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 084765 | Sun Pharm Industries | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 084766 | Sun Pharm Industries | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 085376 | Impax Labs | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 085455 | Watson Labs | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 085456 | Chartwell Rx | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 085458 | Watson Labs | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 085818 | Watson Labs | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 085840 | Watson Labs | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 087533 | Upsher Smith | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 087534 | Upsher Smith | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 088149 | Pangea | Apr 28, 1983 | 1 | — | Prescription |
| ANDA 088237 | Key Therap | Apr 28, 1983 | 1 | — | Discontinued |
| ANDA 088448 | Abraxis Pharm | Jan 25, 1984 | 1 | — | Discontinued |
| ANDA 088469 | Fresenius Kabi USA | Jan 25, 1984 | 1 | — | Discontinued |
| ANDA 088481 | Alvogen | Apr 28, 1983 | 4 | BP | Prescription |
| ANDA 088997 | Alpharma US Pharms | Oct 10, 1986 | 1 | — | Discontinued |
| ANDA 089170 | Watson Labs | May 09, 1989 | 1 | — | Discontinued |
| ANDA 090891 | Rising | Jul 12, 2011 | 1 | AA | Prescription |
| ANDA 091188 | Chartwell Molecular | May 11, 2011 | 1 | AA | Prescription |
| ANDA 201270 | Pharmobedient | Jul 17, 2017 | 1 | AB | Prescription |
| ANDA 215106 | Amneal | Oct 14, 2021 | 2 | AB | Prescription |
| ANDA 215604 | Novitium Pharma | Oct 05, 2023 | 5 | AB | Prescription |
| ANDA 216282 | Zydus Lifesciences | Feb 07, 2024 | 5 | AB | Prescription |
| ANDA 216283 | Zydus Lifesciences | Feb 07, 2024 | 1 | AB | Prescription |
| ANDA 216284 | Zydus Lifesciences | May 09, 2024 | 1 | AB | Prescription |
| ANDA 216295 | Amneal | Sep 08, 2022 | 1 | AB | Prescription |
| ANDA 217001 | Bionpharma | Apr 19, 2023 | 2 | AB | Prescription |
| ANDA 217538 | Bionpharma | Apr 26, 2023 | 1 | AB | Prescription |
| ANDA 217695 | Apotex | Aug 23, 2023 | 7 | AB | Prescription |
| ANDA 217696 | Novitium Pharma | May 09, 2023 | 1 | AB | Prescription |
| ANDA 218372 | Corepharma | Sep 17, 2024 | 7 | AB | Prescription |
Active-ingredient family
Brand + generics
Generic (ANDA) of Dexamethasone
- 2019HemadyBrand (NDA)
NDA 211379 · Dexcel
- 2018DextenzaBrand (NDA)
NDA 208742 · Ocular Therapeutix
- 2018Dexycu KitBrand (NDA)
NDA 208912 · Eyepoint Pharms
- 2009OzurdexBrand (NDA)
NDA 022315 · Abbvie
- —DecasprayBrand (NDA)
NDA 012731 · Merck
- —DecadronBrand (NDA)
NDA 012376 · Merck
- —HexadrolBrand (NDA)
NDA 012674 · Aspen Global Inc
- —DecadermBrand (NDA)
NDA 013538 · Merck
- —MaxidexBrand (NDA)
NDA 013422 · Harrow Eye
- —DecadronBrand (NDA)
NDA 011664 · Merck
- —HexadrolBrand (NDA)
NDA 012675 · Aspen Global Inc
- 1983Dexamethasone IntensolGeneric (ANDA)
ANDA 088252 · Hikma
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.
Dexamethasone: 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 084612 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
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