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 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 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 3 of 6 · 220 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 2024-05-31 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…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 87673890dc5c…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.