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 2 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 2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 8072bd15b7f6…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.