Application 021443

Type: NDA
Sponsor: ASPEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	TABLET;ORAL	0.3MG	No	No
002	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	TABLET;ORAL	0.45MG	No	No
003	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	TABLET;ORAL	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
004	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	TABLET;ORAL	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
005	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	TABLET;ORAL	0.9MG	No	No

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

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	Approval date
N021443-001	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	0.3MG	TABLET / ORAL	2004-12-20
N021443-002	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	0.45MG	TABLET / ORAL	2004-12-20
N021443-003	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10
N021443-004	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10
N021443-005	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	0.9MG	TABLET / ORAL	2007-04-27

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 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021443-001	ENJUVIA	0.3MG	TABLET / ORAL	2004-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021443-002	ENJUVIA	0.45MG	TABLET / ORAL	2004-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021443-003	ENJUVIA	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021443-004	ENJUVIA	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021443-005	ENJUVIA	0.9MG	TABLET / ORAL	2007-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021443-001	ENJUVIA	0.3MG	TABLET / ORAL	2004-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021443-002	ENJUVIA	0.45MG	TABLET / ORAL	2004-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021443-003	ENJUVIA	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021443-004	ENJUVIA	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021443-005	ENJUVIA	0.9MG	TABLET / ORAL	2007-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021443-001	ENJUVIA	0.3MG	TABLET / ORAL	2004-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021443-002	ENJUVIA	0.45MG	TABLET / ORAL	2004-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021443-003	ENJUVIA	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021443-004	ENJUVIA	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021443-005	ENJUVIA	0.9MG	TABLET / ORAL	2007-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021443-001	ENJUVIA	0.3MG	TABLET / ORAL	2004-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021443-002	ENJUVIA	0.45MG	TABLET / ORAL	2004-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021443-003	ENJUVIA	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021443-004	ENJUVIA	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021443-005	ENJUVIA	0.9MG	TABLET / ORAL	2007-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021443-001	ENJUVIA	0.3MG	TABLET / ORAL	2004-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021443-002	ENJUVIA	0.45MG	TABLET / ORAL	2004-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021443-003	ENJUVIA	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021443-004	ENJUVIA	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021443-005	ENJUVIA	0.9MG	TABLET / ORAL	2007-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021443-001	ENJUVIA	0.3MG	TABLET / ORAL	2004-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021443-002	ENJUVIA	0.45MG	TABLET / ORAL	2004-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021443-003	ENJUVIA	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021443-004	ENJUVIA	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021443-005	ENJUVIA	0.9MG	TABLET / ORAL	2007-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021443-001	ENJUVIA	0.3MG	TABLET / ORAL	2004-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021443-002	ENJUVIA	0.45MG	TABLET / ORAL	2004-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021443-003	ENJUVIA	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021443-004	ENJUVIA	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021443-005	ENJUVIA	0.9MG	TABLET / ORAL	2007-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021443-001	ENJUVIA	0.3MG	TABLET / ORAL	2004-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021443-002	ENJUVIA	0.45MG	TABLET / ORAL	2004-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021443-003	ENJUVIA	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021443-004	ENJUVIA	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2004-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021443-005	ENJUVIA	0.9MG	TABLET / ORAL	2007-04-27	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021443-001	6855703	2021-02-12	U-905	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-001	6855703	2021-02-12	U-904	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-001	6660726	2021-03-08	U-905	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-001	6660726	2021-03-08	U-904	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-002	6855703	2021-02-12	U-905	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-002	6855703	2021-02-12	U-904	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-002	6660726	2021-03-08	U-905	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-002	6660726	2021-03-08	U-904	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-003	6855703	2021-02-12	U-905	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-003	6855703	2021-02-12	U-904	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-003	6660726	2021-03-08	U-905	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-003	6660726	2021-03-08	U-904	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-004	6855703	2021-02-12	U-904	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-004	6855703	2021-02-12	U-905	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-004	6660726	2021-03-08	U-905	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-004	6660726	2021-03-08	U-904	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-005	6855703	2021-02-12	U-905	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-005	6855703	2021-02-12	U-904	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-005	6660726	2021-03-08	U-905	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021443-005	6660726	2021-03-08	U-904	Drug substance, Drug product	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021443-001	6855703	2021-02-12	U-905	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-001	6855703	2021-02-12	U-904	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-001	6660726	2021-03-08	U-905	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-001	6660726	2021-03-08	U-904	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-002	6855703	2021-02-12	U-905	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-002	6855703	2021-02-12	U-904	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-002	6660726	2021-03-08	U-905	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-002	6660726	2021-03-08	U-904	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-003	6855703	2021-02-12	U-905	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-003	6855703	2021-02-12	U-904	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-003	6660726	2021-03-08	U-905	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-003	6660726	2021-03-08	U-904	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-004	6855703	2021-02-12	U-904	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-004	6855703	2021-02-12	U-905	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-004	6660726	2021-03-08	U-904	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-004	6660726	2021-03-08	U-905	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-005	6855703	2021-02-12	U-905	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-005	6855703	2021-02-12	U-904	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-005	6660726	2021-03-08	U-905	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021443-005	6660726	2021-03-08	U-904	Drug substance, Drug product	`782e0a99824c…`

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85029	SUPPL	2026-02-12
85019	SUPPL	2026-02-12
77539	SUPPL	2024-02-16
77523	SUPPL	2024-02-16
65472	SUPPL	2020-12-02
65471	SUPPL	2020-12-02
65447	SUPPL	2020-12-01
65446	SUPPL	2020-12-01
50271	SUPPL	2017-11-02
27793	SUPPL	2015-07-09
36936	SUPPL	2015-07-01
27792	SUPPL	2007-05-01
27791	SUPPL	2007-05-01
15475	SUPPL	2007-04-25
42168	ORIG	2006-07-27
27790	ORIG	2004-05-26
15474	ORIG	2004-05-19