FDA application holder
Pfizer Inc
The Orange Book identifies this organization as the applicant responsible for ANDA 085635.
Orange Book drug · Generic (ANDA)
Depo-testosterone
Testosterone Cypionate
RLDANDA 085635 3 strengths Pfizer
Approved
Prior to Jan 1, 1982
Strengths
3
Listed patents
0
What does the FDA Orange Book show for Depo-testosterone?
Depo-testosterone contains Testosterone Cypionate and is the generic drug FDA Orange Book record for ANDA 085635. The application has 3 presentations 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 085635
- Application holder
- Pfizer Inc
- Product presentations
- 3
- Marketing categories
- Discontinued and Prescription
- Reference roles
- RLD / RS
- TE codes
- AO
- 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 | 50MG/ML | INJECTABLEINJECTION | Discontinued | None posted | None posted |
| 002 | 100MG/ML | INJECTABLEINJECTION | Prescription | AO | RLDRS |
| 003 | 200MG/ML | INJECTABLEINJECTION | Prescription | AO | 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
Status varies by presentation: 1 on the Discontinued Drug Product List and 2 prescription
Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.
Therapeutic equivalence
TE code AO across rated presentations
An AO code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group. 1 presentation in the application has no posted TE 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
14 other ANDAs and 1 other NDA found
8 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 085635 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
Testosterone Cypionate
- Product rows
- 24
- Active applications
- 9
- Active with AB row
- 0
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue ANDA-085635
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
3 approved presentations · ANDA 085635
Discontinued
- Strength
- 50MG/ML
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Discontinued
Key dates
Approval, patents, exclusivityNo patent or exclusivity dates are listed for this product.
Pharmaceutical detail
FDA product recordActive ingredient
TESTOSTERONE CYPIONATE
Strength
50MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 085635
Product number
001
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.
TE AORLDRS
- Strength
- 100MG/ML
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityNo patent or exclusivity dates are listed for this product.
Pharmaceutical detail
FDA product recordActive ingredient
TESTOSTERONE CYPIONATE
Strength
100MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AO
Application
ANDA 085635
Product number
002
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 AORLDRS
- Strength
- 200MG/ML
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityNo patent or exclusivity dates are listed for this product.
Pharmaceutical detail
FDA product recordActive ingredient
TESTOSTERONE CYPIONATE
Strength
200MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AO
Application
ANDA 085635
Product number
003
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
Generic (ANDA) of Testosterone Cypionate
- 2022AzmiroBrand (NDA)
NDA 216318 · Azurity
- 2023Testosterone CypionateGeneric (ANDA)
ANDA 211817 · Eugia Pharma
- 2023Testosterone CypionateGeneric (ANDA)
ANDA 215351 · Xiromed
- 2019Testosterone CypionateGeneric (ANDA)
ANDA 206368 · Wilshire Pharms Inc
- 2018Testosterone CypionateGeneric (ANDA)
ANDA 210362 · Cipla
- 2017Testosterone CypionateGeneric (ANDA)
ANDA 207742 · Am Regent
- 2013Testosterone CypionateGeneric (ANDA)
ANDA 201720 · Sun Pharm Inds Ltd
- 2012Testosterone CypionateGeneric (ANDA)
ANDA 091244 · Hikma Farmaceutica
- 2010Testosterone CypionateGeneric (ANDA)
ANDA 090387 · Hikma
- 2006Testosterone CypionateGeneric (ANDA)
ANDA 040652 · Rising
- 2006Testosterone CypionateGeneric (ANDA)
ANDA 040615 · Caplin One Labs
- 2005Testosterone CypionateGeneric (ANDA)
ANDA 040530 · Padagis US
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.
Depo-testosterone: 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 085635 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
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