Application 020655
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALORA | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.05MG/24HR | No | No |
| 002 | ALORA | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.075MG/24HR | No | No |
| 003 | ALORA | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.1MG/24HR | No | No |
| 004 | ALORA | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.025MG/24HR | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020655-001 | ALORA | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | ||
| N020655-002 | ALORA | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | ||
| N020655-003 | ALORA | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | ||
| N020655-004 | ALORA | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2002-04-05 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020655-001 | ALORA | 0.05MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020655-002 | ALORA | 0.075MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020655-003 | ALORA | 0.1MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020655-004 | ALORA | 0.025MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2002-04-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020655-001 | ALORA | 0.05MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020655-002 | ALORA | 0.075MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020655-003 | ALORA | 0.1MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020655-004 | ALORA | 0.025MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2002-04-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020655-001 | ALORA | 0.05MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020655-002 | ALORA | 0.075MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020655-003 | ALORA | 0.1MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020655-004 | ALORA | 0.025MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2002-04-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020655-001 | ALORA | 0.05MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020655-002 | ALORA | 0.075MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020655-003 | ALORA | 0.1MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020655-004 | ALORA | 0.025MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2002-04-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020655-001 | ALORA | 0.05MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020655-002 | ALORA | 0.075MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020655-003 | ALORA | 0.1MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020655-004 | ALORA | 0.025MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2002-04-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020655-001 | ALORA | 0.05MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020655-002 | ALORA | 0.075MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020655-003 | ALORA | 0.1MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020655-004 | ALORA | 0.025MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2002-04-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020655-001 | ALORA | 0.05MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020655-002 | ALORA | 0.075MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020655-003 | ALORA | 0.1MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020655-004 | ALORA | 0.025MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2002-04-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020655-001 | ALORA | 0.05MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020655-002 | ALORA | 0.075MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020655-003 | ALORA | 0.1MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020655-004 | ALORA | 0.025MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2002-04-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020655-001 | ALORA | 0.05MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020655-002 | ALORA | 0.075MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020655-003 | ALORA | 0.1MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020655-004 | ALORA | 0.025MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2002-04-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020655-001 | ALORA | 0.05MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020655-002 | ALORA | 0.075MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020655-003 | ALORA | 0.1MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1996-12-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020655-004 | ALORA | 0.025MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2002-04-05 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020655-001 | BX | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020655-002 | BX | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020655-003 | BX | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020655-004 | BX | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020655-001 | BX | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020655-002 | BX | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020655-003 | BX | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020655-004 | BX | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020655-001 | BX | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020655-002 | BX | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020655-003 | BX | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020655-004 | BX | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020655-001 | BX | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020655-002 | BX | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020655-003 | BX | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020655-004 | BX | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020655-001 | BX | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020655-002 | BX | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020655-003 | BX | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020655-004 | BX | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020655-001 | BX | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020655-002 | BX | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020655-003 | BX | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020655-004 | BX | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020655-001 | BX | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020655-002 | BX | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020655-003 | BX | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020655-004 | BX | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020655-001 | BX | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020655-002 | BX | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020655-003 | BX | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020655-004 | BX | 1 | ea99ee380514… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Estradiol | ESTRADIOL | Mylan Pharmaceuticals Inc. | d28bec8f-762e-4f05-a20d-96a42970d6a7 | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | NorthStar Rx LLC | 0c8a07a4-5762-eaf4-e063-6394a90a54ff | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol Vaginal Cream | ESTRADIOL | Prasco Laboratories | c895ac14-5dbd-4201-bf3e-ba7c38a4e994 | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | American Health Packaging | 265a1ee1-f314-4324-a2e1-0120a9a00a20 | 2025-05-02 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | 9956a196-fefd-4766-a225-e154fbd3aeff | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 3e84e3e7-4b50-407f-a215-45363b541384 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Preferred Pharmaceuticals Inc. | 72fbd5a8-9c34-4790-84ed-79f5bd3ae0f0 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | fad3813c-9495-416b-9789-623d5758b4e3 | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | cf1ebc1d-8f3c-4468-b565-f0da69986e7c | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | bfc1beb9-1ade-446e-97dd-55b41c2fa851 | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | PD-Rx Pharmaceuticals, Inc. | d0d1c2c8-b175-4250-9343-d7db65b72e8f | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | NuCare Pharmaceuticals,Inc. | dd7d2d2a-e76b-7dfe-e053-2995a90a790a | 2025-02-26 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | PD-Rx Pharmaceuticals, Inc. | aa396e57-0a93-49cc-82e5-cd35c987bb0b | 2025-02-20 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | A-S Medication Solutions | 8788ddd1-36a6-416a-b527-75eb41de2808 | 2025-02-18 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol Vaginal | ESTRADIOL | NuCare Pharmaceuticals, Inc. | 2e5a4d78-6683-4fb8-e063-6294a90a49e7 | 2025-02-17 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | 487ce40e-1f13-4497-994a-c5d91b87b6cc | 2025-02-13 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Vagifem | ESTRADIOL | Novo Nordisk | e5ad3cf6-dd96-4e64-af21-c1eee38d0b88 | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Direct_Rx | 032135ee-7bc9-5cdf-e063-6394a90ad9a2 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | Direct_Rx | 01789bad-4be4-ae22-e063-6294a90af392 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
| Estradiol | ESTRADIOL | PharmPak, Inc. | 20b50139-4e13-4f0c-aaf5-ecb83911d9e6 | 2025-01-16 | Boxed warning, Warnings, Adverse reactions | ESTRADIOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-5885 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5885 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5885 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5885 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5885 | Alora | Estradiol Transdermal System | Allergan, Inc. | NDA | Current |
| 0023-5886 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5886 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5886 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5886 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5886 | Alora | Estradiol Transdermal System | Allergan, Inc. | NDA | Current |
| 0023-5887 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5887 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5887 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5887 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5887 | Alora | Estradiol Transdermal System | Allergan, Inc. | NDA | Current |
| 0023-5888 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5888 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5888 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5888 | Alora | Estradiol | Allergan, Inc. | NDA | Current |
| 0023-5888 | Alora | Estradiol Transdermal System | Allergan, Inc. | NDA | Current |
| 52544-471 | Alora | Estradiol | Actavis Pharma, Inc. | NDA | Current |
| 52544-471 | Alora | Estradiol | Actavis Pharma, Inc. | NDA | Current |
| 52544-471 | Alora | Estradiol | Actavis Pharma, Inc. | NDA | Current |
| 52544-471 | Alora | Estradiol Transdermal System | Actavis Pharma, Inc. | NDA | Current |
| 52544-472 | Alora | Estradiol | Actavis Pharma, Inc. | NDA | Current |
| 52544-472 | Alora | Estradiol | Actavis Pharma, Inc. | NDA | Current |
| 52544-472 | Alora | Estradiol | Actavis Pharma, Inc. | NDA | Current |
| 52544-472 | Alora | Estradiol Transdermal System | Actavis Pharma, Inc. | NDA | Current |
| 52544-473 | Alora | Estradiol | Actavis Pharma, Inc. | NDA | Current |
| 52544-473 | Alora | Estradiol | Actavis Pharma, Inc. | NDA | Current |
| 52544-473 | Alora | Estradiol | Actavis Pharma, Inc. | NDA | Current |
| 52544-473 | Alora | Estradiol Transdermal System | Actavis Pharma, Inc. | NDA | Current |
| 52544-884 | Alora | Estradiol | Actavis Pharma, Inc. | NDA | Current |
| 52544-884 | Alora | Estradiol | Actavis Pharma, Inc. | NDA | Current |
| 52544-884 | Alora | Estradiol | Actavis Pharma, Inc. | NDA | Current |
| 52544-884 | Alora | Estradiol Transdermal System | Actavis Pharma, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82164 | SUPPL | 2025-05-08 |
| 82260 | SUPPL | 2025-05-05 |
| 77530 | SUPPL | 2024-02-16 |
| 77517 | SUPPL | 2024-02-16 |
| 62369 | SUPPL | 2020-03-31 |
| 62367 | SUPPL | 2020-03-31 |
| 50261 | SUPPL | 2017-11-02 |
| 35078 | SUPPL | 2005-05-20 |
| 25447 | SUPPL | 2005-05-20 |
| 41523 | SUPPL | 2004-05-27 |
| 12923 | SUPPL | 2003-12-01 |
| 25446 | SUPPL | 2003-11-26 |
| 12924 | SUPPL | 2002-04-05 |
| 2998 | SUPPL | 2002-04-05 |