Application 083266

Type
ANDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMNESTROGENESTROGENS, ESTERIFIEDTABLET;ORAL0.3MGNoNo
002AMNESTROGENESTROGENS, ESTERIFIEDTABLET;ORAL0.625MGNoNo
003AMNESTROGENESTROGENS, ESTERIFIEDTABLET;ORAL1.25MGNoNo
004AMNESTROGENESTROGENS, ESTERIFIEDTABLET;ORAL2.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A083266-001AMNESTROGENESTROGENS, ESTERIFIED0.3MGTABLET / ORALApproved before 1982
A083266-002AMNESTROGENESTROGENS, ESTERIFIED0.625MGTABLET / ORALApproved before 1982
A083266-003AMNESTROGENESTROGENS, ESTERIFIED1.25MGTABLET / ORALApproved before 1982
A083266-004AMNESTROGENESTROGENS, ESTERIFIED2.5MGTABLET / ORALApproved 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 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A083266-001AMNESTROGEN0.3MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A083266-002AMNESTROGEN0.625MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A083266-003AMNESTROGEN1.25MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A083266-004AMNESTROGEN2.5MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A083266-001AMNESTROGEN0.3MGTABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083266-002AMNESTROGEN0.625MGTABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083266-003AMNESTROGEN1.25MGTABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083266-004AMNESTROGEN2.5MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083266-001AMNESTROGEN0.3MGTABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083266-002AMNESTROGEN0.625MGTABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083266-003AMNESTROGEN1.25MGTABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083266-004AMNESTROGEN2.5MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A083266-001AMNESTROGEN0.3MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083266-002AMNESTROGEN0.625MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083266-003AMNESTROGEN1.25MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083266-004AMNESTROGEN2.5MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083266-001AMNESTROGEN0.3MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083266-002AMNESTROGEN0.625MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083266-003AMNESTROGEN1.25MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083266-004AMNESTROGEN2.5MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083266-001AMNESTROGEN0.3MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083266-002AMNESTROGEN0.625MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083266-003AMNESTROGEN1.25MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083266-004AMNESTROGEN2.5MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083266-001AMNESTROGEN0.3MGTABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083266-002AMNESTROGEN0.625MGTABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083266-003AMNESTROGEN1.25MGTABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083266-004AMNESTROGEN2.5MGTABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083266-001AMNESTROGEN0.3MGTABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083266-002AMNESTROGEN0.625MGTABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083266-003AMNESTROGEN1.25MGTABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083266-004AMNESTROGEN2.5MGTABLET / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083266-001AMNESTROGEN0.3MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083266-002AMNESTROGEN0.625MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083266-003AMNESTROGEN1.25MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083266-004AMNESTROGEN2.5MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083266-001AMNESTROGEN0.3MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083266-002AMNESTROGEN0.625MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083266-003AMNESTROGEN1.25MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083266-004AMNESTROGEN2.5MGTABLET / ORALApproved before 1982d8e5a09893c0…