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ESTROGENS, CONJUGATED SYNTHETIC A	TABLET;ORAL	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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CONJUGATED SYNTHETIC A	TABLET;ORAL	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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ESTROGENS, CONJUGATED SYNTHETIC A	TABLET;ORAL	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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CONJUGATED SYNTHETIC A	TABLET;ORAL	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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CONJUGATED SYNTHETIC A	TABLET;ORAL	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-06-21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CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24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CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-03-24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CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-03-13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CENESTIN	ESTROGENS, CONJUGATED SYNTHETIC A	0.45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-02-05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 5 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
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`

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