Application 020992

Type
NDA
Sponsor
ASPEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CENESTINESTROGENS, CONJUGATED SYNTHETIC ATABLET;ORAL0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CENESTINESTROGENS, CONJUGATED SYNTHETIC ATABLET;ORAL0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003CENESTINESTROGENS, CONJUGATED SYNTHETIC ATABLET;ORAL0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004CENESTINESTROGENS, CONJUGATED SYNTHETIC ATABLET;ORAL1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005CENESTINESTROGENS, CONJUGATED SYNTHETIC ATABLET;ORAL0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020992-001CENESTINESTROGENS, CONJUGATED SYNTHETIC A0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-06-21
N020992-002CENESTINESTROGENS, CONJUGATED SYNTHETIC A0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-03-24
N020992-003CENESTINESTROGENS, CONJUGATED SYNTHETIC A0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-03-24
N020992-004CENESTINESTROGENS, CONJUGATED SYNTHETIC A1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-03-13
N020992-005CENESTINESTROGENS, CONJUGATED SYNTHETIC A0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-02-05

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 6 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020992-001CENESTIN0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-06-21f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020992-002CENESTIN0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-03-24f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020992-003CENESTIN0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-03-24f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020992-004CENESTIN1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-03-13f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020992-005CENESTIN0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-02-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020992-001CENESTIN0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-06-21e64feba35796…
2022-09-29 23:25 UTC2022-09N020992-002CENESTIN0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-03-24e64feba35796…
2022-09-29 23:25 UTC2022-09N020992-003CENESTIN0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-03-24e64feba35796…
2022-09-29 23:25 UTC2022-09N020992-004CENESTIN1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-03-13e64feba35796…
2022-09-29 23:25 UTC2022-09N020992-005CENESTIN0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-02-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020992-001CENESTIN0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-06-21cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020992-002CENESTIN0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-03-24cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020992-003CENESTIN0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-03-24cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020992-004CENESTIN1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-03-13cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020992-005CENESTIN0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-02-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020992-001CENESTIN0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2002-06-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020992-002CENESTIN0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-03-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020992-003CENESTIN0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-03-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020992-004CENESTIN1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-03-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020992-005CENESTIN0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-02-05a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85030SUPPL 2026-02-12
85018SUPPL 2026-02-12
77532SUPPL 2024-02-16
77521SUPPL 2024-02-16
65474SUPPL2020-12-02
65473SUPPL2020-12-02
65449SUPPL2020-12-01
65448SUPPL2020-12-01
50263SUPPL2017-11-02
26433SUPPL2015-03-24
14125SUPPL2015-03-24
21336SUPPL2007-06-18
35842SUPPL2004-11-01
3998SUPPL2004-10-29
35841SUPPL2004-04-05
26431SUPPL2004-03-03
26432SUPPL2004-02-02
26430SUPPL2002-06-21
14124SUPPL2002-06-21
3997SUPPL2002-02-22
26429ORIG1999-03-24
21335ORIG1999-03-24
14123ORIG1999-03-24