Application 020992

Type: NDA
Sponsor: ASPEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	TABLET;ORAL	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	TABLET;ORAL	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	TABLET;ORAL	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	TABLET;ORAL	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	TABLET;ORAL	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

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	Approval date
N020992-001	CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-06-21
N020992-002	CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24
N020992-003	CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24
N020992-004	CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-03-13
N020992-005	CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-02-05

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 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020992-001	CENESTIN	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020992-002	CENESTIN	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020992-003	CENESTIN	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020992-004	CENESTIN	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020992-005	CENESTIN	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020992-001	CENESTIN	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020992-002	CENESTIN	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020992-003	CENESTIN	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020992-004	CENESTIN	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020992-005	CENESTIN	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020992-001	CENESTIN	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020992-002	CENESTIN	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020992-003	CENESTIN	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020992-004	CENESTIN	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020992-005	CENESTIN	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020992-001	CENESTIN	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020992-002	CENESTIN	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020992-003	CENESTIN	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020992-004	CENESTIN	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-03-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020992-005	CENESTIN	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020992-001	CENESTIN	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020992-002	CENESTIN	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020992-003	CENESTIN	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020992-004	CENESTIN	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-03-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020992-005	CENESTIN	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020992-001	CENESTIN	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020992-002	CENESTIN	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020992-003	CENESTIN	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020992-004	CENESTIN	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-03-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020992-005	CENESTIN	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020992-001	CENESTIN	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020992-002	CENESTIN	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020992-003	CENESTIN	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020992-004	CENESTIN	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-03-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020992-005	CENESTIN	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020992-001	CENESTIN	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-06-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020992-002	CENESTIN	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020992-003	CENESTIN	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020992-004	CENESTIN	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-03-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020992-005	CENESTIN	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-02-05	`8072bd15b7f6…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85030	SUPPL	2026-02-12
85018	SUPPL	2026-02-12
77532	SUPPL	2024-02-16
77521	SUPPL	2024-02-16
65474	SUPPL	2020-12-02
65473	SUPPL	2020-12-02
65449	SUPPL	2020-12-01
65448	SUPPL	2020-12-01
50263	SUPPL	2017-11-02
26433	SUPPL	2015-03-24
14125	SUPPL	2015-03-24
21336	SUPPL	2007-06-18
35842	SUPPL	2004-11-01
3998	SUPPL	2004-10-29
35841	SUPPL	2004-04-05
26431	SUPPL	2004-03-03
26432	SUPPL	2004-02-02
26430	SUPPL	2002-06-21
14124	SUPPL	2002-06-21
3997	SUPPL	2002-02-22
26429	ORIG	1999-03-24
21335	ORIG	1999-03-24
14123	ORIG	1999-03-24