Application 085470

Type: ANDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEPO-ESTRADIOL	ESTRADIOL CYPIONATE	INJECTABLE;INJECTION	1MG/ML	No	No
002	DEPO-ESTRADIOL	ESTRADIOL CYPIONATE	INJECTABLE;INJECTION	3MG/ML	No	No
003	DEPO-ESTRADIOL	ESTRADIOL CYPIONATE	INJECTABLE;INJECTION	5MG/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	RLD / RS
A085470-001	DEPO-ESTRADIOL	ESTRADIOL CYPIONATE	1MG/ML	INJECTABLE / INJECTION	Approved before 1982
A085470-002	DEPO-ESTRADIOL	ESTRADIOL CYPIONATE	3MG/ML	INJECTABLE / INJECTION	Approved before 1982
A085470-003	DEPO-ESTRADIOL	ESTRADIOL CYPIONATE	5MG/ML	INJECTABLE / INJECTION	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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A085470-003	DEPO-ESTRADIOL	5MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085470-001	DEPO-ESTRADIOL	1MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A085470-002	DEPO-ESTRADIOL	3MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`

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
Depo-Estradiol	ESTRADIOL CYPIONATE	Pharmacia & Upjohn Company LLC	9a4229fd-fecd-4ac1-9c4f-6d442533457f	2024-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085470 application number: ANDA085470 ndc (product): 0009-0271

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0271	Depo-Estradiol	estradiol cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current
0009-0271	Depo-Estradiol	estradiol cypionate	Pharmacia & Upjohn Company LLC	ANDA	Current
0009-0271	Depo-Estradiol	estradiol cypionate	Pharmacia and Upjohn Company LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39588	SUPPL	2009-09-30