Application 080911

Type: ANDA
Sponsor: AUXILIUM PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESTOPEL	TESTOSTERONE	PELLET;IMPLANTATION	75MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080911-001	TESTOPEL	TESTOSTERONE	75MG	PELLET / IMPLANTATION		RS, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A080911-001	TESTOPEL	75MG	PELLET / IMPLANTATION	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080911-001	TESTOPEL	75MG	PELLET / IMPLANTATION	RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080911-001	TESTOPEL	75MG	PELLET / IMPLANTATION	RS, Approved before 1982	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Testopel	TESTOSTERONE	Endo USA, Inc.	03b9c0b1-5884-11e4-8ed6-0800200c9a66	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080911 application number: ANDA080911 ndc (product): 66887-004

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43773-1001	Testopel	TESTOSTERONE	Slate Pharma	ANDA	Current
66887-004	Testopel	testosterone	Endo Pharmaceuticals, Inc.	ANDA	Current
66887-004	Testopel	testosterone	Endo Pharmaceuticals Inc.	ANDA	Current
66887-004	Testopel	testosterone	Endo Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22639	SUPPL	2007-07-09