Application 004039

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DIETHYLSTILBESTROL	DIETHYLSTILBESTROL	TABLET, DELAYED RELEASE;ORAL	0.1MG	No	No
003	DIETHYLSTILBESTROL	DIETHYLSTILBESTROL	TABLET, DELAYED RELEASE;ORAL	0.5MG	No	No
004	DIETHYLSTILBESTROL	DIETHYLSTILBESTROL	TABLET, DELAYED RELEASE;ORAL	1MG	No	No
005	DIETHYLSTILBESTROL	DIETHYLSTILBESTROL	TABLET, DELAYED RELEASE;ORAL	0.25MG	No	No
006	DIETHYLSTILBESTROL	DIETHYLSTILBESTROL	TABLET, DELAYED RELEASE;ORAL	5MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N004039-002	DIETHYLSTILBESTROL	DIETHYLSTILBESTROL	0.1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982
N004039-003	DIETHYLSTILBESTROL	DIETHYLSTILBESTROL	0.5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982
N004039-004	DIETHYLSTILBESTROL	DIETHYLSTILBESTROL	1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982
N004039-005	DIETHYLSTILBESTROL	DIETHYLSTILBESTROL	0.25MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982
N004039-006	DIETHYLSTILBESTROL	DIETHYLSTILBESTROL	5MG	TABLET, DELAYED RELEASE / ORAL	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 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N004039-002	DIETHYLSTILBESTROL	0.1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N004039-003	DIETHYLSTILBESTROL	0.5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N004039-004	DIETHYLSTILBESTROL	1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N004039-005	DIETHYLSTILBESTROL	0.25MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N004039-006	DIETHYLSTILBESTROL	5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N004039-002	DIETHYLSTILBESTROL	0.1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N004039-003	DIETHYLSTILBESTROL	0.5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N004039-004	DIETHYLSTILBESTROL	1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N004039-005	DIETHYLSTILBESTROL	0.25MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N004039-006	DIETHYLSTILBESTROL	5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N004039-002	DIETHYLSTILBESTROL	0.1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N004039-003	DIETHYLSTILBESTROL	0.5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N004039-004	DIETHYLSTILBESTROL	1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N004039-005	DIETHYLSTILBESTROL	0.25MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N004039-006	DIETHYLSTILBESTROL	5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N004039-002	DIETHYLSTILBESTROL	0.1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N004039-003	DIETHYLSTILBESTROL	0.5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N004039-004	DIETHYLSTILBESTROL	1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N004039-005	DIETHYLSTILBESTROL	0.25MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N004039-006	DIETHYLSTILBESTROL	5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N004039-002	DIETHYLSTILBESTROL	0.1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N004039-003	DIETHYLSTILBESTROL	0.5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N004039-004	DIETHYLSTILBESTROL	1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N004039-005	DIETHYLSTILBESTROL	0.25MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N004039-006	DIETHYLSTILBESTROL	5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N004039-002	DIETHYLSTILBESTROL	0.1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N004039-003	DIETHYLSTILBESTROL	0.5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N004039-004	DIETHYLSTILBESTROL	1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N004039-005	DIETHYLSTILBESTROL	0.25MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N004039-006	DIETHYLSTILBESTROL	5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N004039-002	DIETHYLSTILBESTROL	0.1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N004039-003	DIETHYLSTILBESTROL	0.5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N004039-004	DIETHYLSTILBESTROL	1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N004039-005	DIETHYLSTILBESTROL	0.25MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N004039-006	DIETHYLSTILBESTROL	5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N004039-002	DIETHYLSTILBESTROL	0.1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N004039-003	DIETHYLSTILBESTROL	0.5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N004039-004	DIETHYLSTILBESTROL	1MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N004039-005	DIETHYLSTILBESTROL	0.25MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N004039-006	DIETHYLSTILBESTROL	5MG	TABLET, DELAYED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`

Reported adverse events (FAERS/openFDA)#

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

Application 004039

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#