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 5 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 2023-12-20 04:57 UTC 2023-12 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N010976-004 ENOVID 0.075MG;5MG TABLET / ORAL-20 Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N010976-005 ENOVID 0.15MG;9.85MG TABLET / ORAL Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N010976-006 ENOVID-E 0.1MG;2.5MG TABLET / ORAL-20 Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N010976-007 ENOVID-E 21 0.1MG;2.5MG TABLET / ORAL-21 Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N010976-008 ENOVID 0.075MG;5MG TABLET / ORAL Approved before 1982 3a93d1ddd44b…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.