Application 085635

Type: ANDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	INJECTABLE;INJECTION	50MG/ML	No	No
002	DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	INJECTABLE;INJECTION	100MG/ML	No	Yes
003	DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	INJECTABLE;INJECTION	200MG/ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
A085635-001	DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982
A085635-002	DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982
A085635-003	DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A085635-002	AO
A085635-003	AO

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A085635-002	AO	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A085635-003	AO	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A085635-002	AO	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A085635-003	AO	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085635-002	AO	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085635-003	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085635-002	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085635-003	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085635-002	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085635-003	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085635-002	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085635-003	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085635-002	AO	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085635-003	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085635-002	AO	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085635-003	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085635-002	AO	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085635-003	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085635-002	AO	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085635-003	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085635-002	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085635-003	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085635-002	AO	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085635-003	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085635-002	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085635-003	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085635-002	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085635-003	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085635-002	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085635-003	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085635-002	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085635-003	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085635-002	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A085635-003	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085635-002	AO	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085635-003	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085635-002	AO	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A085635-003	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085635-002	AO	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A085635-003	AO	1	`4b0b4de00fa7…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Depo-Testosterone	TESTOSTERONE CYPIONATE	Pharmacia & Upjohn Company LLC	cfbb53d4-b868-4a28-8436-f9112eb01c39	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085635 application number: ANDA085635 ndc (product): 0009-0417 ndc (product): 0009-0347
Depo-Testosterone	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	2f72be32-ede6-44d9-88a0-0653b53a3e47	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085635 application number: ANDA085635
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Hospira, Inc.	6909596e-4bf7-4e11-8029-b89740a30aec	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085635 application number: ANDA085635 ndc (product): 0409-6557 ndc (product): 0409-6562
Depo-Testosterone	TESTOSTERONE CYPIONATE	Pharmacia & Upjohn Company LLC	735b5bf3-4464-412c-a072-1bd02f2e5380	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085635 application number: ANDA085635 ndc (product): 0009-0085 ndc (product): 0009-0086

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0085	Depo-Testosterone	testosterone cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current
0009-0085	Depo-Testosterone	testosterone cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current
0009-0085	Depo-Testosterone	testosterone cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current
0009-0086	Depo-Testosterone	testosterone cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current
0009-0086	Depo-Testosterone	testosterone cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current
0009-0086	Depo-Testosterone	testosterone cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current
0009-0347	Depo-Testosterone	testosterone cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current
0009-0347	Depo-Testosterone	testosterone cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current
0009-0417	Depo-Testosterone	testosterone cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current
0009-0417	Depo-Testosterone	testosterone cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current
0009-0520	Depo-Testosterone	testosterone cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current
0409-6557	Testosterone Cypionate	testosterone cypionate	Hospira, Inc.	ANDA	Current
0409-6557	Testosterone Cypionate	testosterone cypionate	Hospira, Inc.	ANDA	Current
0409-6562	Testosterone Cypionate	testosterone cypionate	Hospira, Inc.	ANDA	Current
0409-6562	Testosterone Cypionate	testosterone cypionate	Hospira, Inc.	ANDA	Current
0409-6562	Testosterone Cypionate	testosterone cypionate	Hospira, Inc.	ANDA	Current
0409-6562	Testosterone Cypionate	testosterone cypionate	Hospira, Inc.	ANDA	Current
50090-0746	Depo-Testosterone	testosterone cypionate	A-S Medication Solutions	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83094	SUPPL	2025-08-12
57501	SUPPL	2019-02-12
18508	SUPPL	2015-05-12
43197	SUPPL	2014-08-06
43196	SUPPL	2014-08-06
22668	SUPPL	2014-08-06
18507	SUPPL	2014-07-16