Home Applications 010976 Application 010976
Type NDA
Sponsor GD SEARLE LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 004 ENOVID MESTRANOL; NORETHYNODREL TABLET;ORAL-20 0.075MG;5MG No No 005 ENOVID MESTRANOL; NORETHYNODREL TABLET;ORAL 0.15MG;9.85MG No No 006 ENOVID-E MESTRANOL; NORETHYNODREL TABLET;ORAL-20 0.1MG;2.5MG No No 007 ENOVID-E 21 MESTRANOL; NORETHYNODREL TABLET;ORAL-21 0.1MG;2.5MG No No 008 ENOVID MESTRANOL; NORETHYNODREL TABLET;ORAL 0.075MG;5MG No 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 TE codes RLD / RS Approval date N010976-004 ENOVID MESTRANOL; NORETHYNODREL 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 N010976-005 ENOVID MESTRANOL; NORETHYNODREL 0.15MG;9.85MG TABLET / ORAL Approved before 1982 N010976-006 ENOVID-E MESTRANOL; NORETHYNODREL 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 N010976-007 ENOVID-E 21 MESTRANOL; NORETHYNODREL 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 N010976-008 ENOVID MESTRANOL; NORETHYNODREL 0.075MG;5MG TABLET / ORAL Approved 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 6 · 215 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 03ed91905a0d…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.