Application 021443
- Type
- NDA
- Sponsor
- ASPEN
Application Products#
| 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CONJUGATED SYNTHETIC B | TABLET;ORAL | 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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CONJUGATED SYNTHETIC B | TABLET;ORAL | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | 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| ESTROGENS, CONJUGATED SYNTHETIC B | 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2004-05-10 | ||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| ESTROGENS, CONJUGATED SYNTHETIC B | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 2004-05-10 | ||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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021443-001 | ENJUVIA | 0.3MG | TABLET / ORAL | 2004-12-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021443-002 | ENJUVIA | 0.45MG | TABLET / ORAL | 2004-12-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | 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 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | 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 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021443-005 | ENJUVIA | 0.9MG | TABLET / ORAL | 2007-04-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021443-001 | ENJUVIA | 0.3MG | TABLET / ORAL | 2004-12-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021443-002 | ENJUVIA | 0.45MG | TABLET / ORAL | 2004-12-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | 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 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | 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 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021443-005 | ENJUVIA | 0.9MG | TABLET / ORAL | 2007-04-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021443-001 | ENJUVIA | 0.3MG | TABLET / ORAL | 2004-12-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021443-002 | ENJUVIA | 0.45MG | TABLET / ORAL | 2004-12-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | 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 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | 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 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021443-005 | ENJUVIA | 0.9MG | TABLET / ORAL | 2007-04-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021443-001 | ENJUVIA | 0.3MG | TABLET / ORAL | 2004-12-20 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021443-002 | ENJUVIA | 0.45MG | TABLET / ORAL | 2004-12-20 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | 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 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | 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 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021443-005 | ENJUVIA | 0.9MG | TABLET / ORAL | 2007-04-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021443-001 | ENJUVIA | 0.3MG | TABLET / ORAL | 2004-12-20 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021443-002 | ENJUVIA | 0.45MG | TABLET / ORAL | 2004-12-20 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021443-005 | ENJUVIA | 0.9MG | TABLET / ORAL | 2007-04-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021443-001 | ENJUVIA | 0.3MG | TABLET / ORAL | 2004-12-20 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021443-002 | ENJUVIA | 0.45MG | TABLET / ORAL | 2004-12-20 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021443-005 | ENJUVIA | 0.9MG | TABLET / ORAL | 2007-04-27 | 1e350fbaab3a… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| 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 |