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ESTROGENS, CONJUGATED SYNTHETIC A	TABLET;ORAL	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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CONJUGATED SYNTHETIC A	TABLET;ORAL	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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ESTROGENS, CONJUGATED SYNTHETIC A	TABLET;ORAL	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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CONJUGATED SYNTHETIC A	TABLET;ORAL	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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CONJUGATED SYNTHETIC A	TABLET;ORAL	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 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	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CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-06-21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CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24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CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24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CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-03-13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CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-02-05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 3 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-05-31 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…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	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	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	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	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	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	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	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	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	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	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020992-001	CENESTIN	0.3MG	TABLET / ORAL	RLD	2002-06-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020992-002	CENESTIN	0.625MG	TABLET / ORAL	RLD	1999-03-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020992-003	CENESTIN	0.9MG	TABLET / ORAL	RLD	1999-03-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020992-004	CENESTIN	1.25MG	TABLET / ORAL	RLD	2000-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020992-005	CENESTIN	0.45MG	TABLET / ORAL	RLD	2004-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020992-001	CENESTIN	0.3MG	TABLET / ORAL	RLD	2002-06-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020992-002	CENESTIN	0.625MG	TABLET / ORAL	RLD	1999-03-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020992-003	CENESTIN	0.9MG	TABLET / ORAL	RLD	1999-03-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020992-004	CENESTIN	1.25MG	TABLET / ORAL	RLD	2000-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020992-005	CENESTIN	0.45MG	TABLET / ORAL	RLD	2004-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020992-001	CENESTIN	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2002-06-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020992-002	CENESTIN	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-03-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020992-003	CENESTIN	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-03-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020992-004	CENESTIN	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2000-03-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020992-005	CENESTIN	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2004-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020992-001	CENESTIN	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2002-06-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020992-002	CENESTIN	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-03-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020992-003	CENESTIN	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-03-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020992-004	CENESTIN	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2000-03-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020992-005	CENESTIN	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2004-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020992-001	CENESTIN	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2002-06-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020992-002	CENESTIN	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-03-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020992-003	CENESTIN	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-03-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020992-004	CENESTIN	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2000-03-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020992-005	CENESTIN	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2004-02-05	`87673890dc5c…`

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