Application 201110
- Type
- NDA
- Sponsor
- Ferring Pharmaceuticals, Inc.
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MILPROSA | PROGESTERONE | RING;VAGINAL | 1.78g | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N201110-001 | MILPROSA | PROGESTERONE | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | |
| N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | |
| N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 |
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 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N201110-001 | MILPROSA | 1.78GM | SYSTEM / VAGINAL | RLD | 2020-04-29 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201110-001 | 10548904 | 2029-02-03 | U-2810 | 2020-05-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201110-001 | 8580293 | 2030-01-21 | U-2810 | 2020-05-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201110-001 | 10537584 | 2029-02-03 | Drug product | 2020-05-19 | 301d65b070ca… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N201110-001 | NP | 2023-04-29 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N201110-001 | NP | 2023-04-29 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N201110-001 | NP | 2023-04-29 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N201110-001 | NP | 2023-04-29 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N201110-001 | NP | 2023-04-29 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N201110-001 | NP | 2023-04-29 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N201110-001 | NP | 2023-04-29 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N201110-001 | NP | 2023-04-29 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N201110-001 | NP | 2023-04-29 | c0c555d07b60… |
| 2023-12-20 04:57 UTC | 2023-12 | N201110-001 | NP | 2023-04-29 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N201110-001 | NP | 2023-04-29 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N201110-001 | NP | 2023-04-29 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N201110-001 | NP | 2023-04-29 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N201110-001 | NP | 2023-04-29 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N201110-001 | NP | 2023-04-29 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N201110-001 | NP | 2023-04-29 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N201110-001 | NP | 2023-04-29 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N201110-001 | NP | 2023-04-29 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N201110-001 | NP | 2023-04-29 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N201110-001 | NP | 2023-04-29 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Progesterone | PROGESTERONE | Amneal Pharmaceuticals LLC | 4de0715d-a3b9-42fa-b4e4-6371151fd75c | 2026-02-24 | Warnings, Adverse reactions | PROGESTERONE |
| Progesterone | PROGESTERONE | Northstar Rx LLC | 73229a76-8de3-4cea-886f-568f0b817fea | 2026-02-19 | Warnings, Adverse reactions | PROGESTERONE |
| Progesterone | PROGESTERONE | Xiromed, LLC | 0bf317a8-96d6-849d-7850-9084205a5315 | 2026-02-17 | Warnings, Adverse reactions | PROGESTERONE |
| PROGESTERONE | PROGESTERONE | Proficient Rx LP | 199c8575-e113-468f-8eb7-c4930030649c | 2026-02-01 | Boxed warning, Warnings, Adverse reactions | PROGESTERONE |
| PROGESTERONE | PROGESTERONE | Bryant Ranch Prepack | 46d97ca6-970f-478f-81ff-1b9a9f6cb2f7 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | PROGESTERONE |
| Progesterone | PROGESTERONE | Preferred Pharmaceuticals Inc. | eca6a7c0-7f58-4dcf-aec0-9d44fd594aa1 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | PROGESTERONE |
| Progesterone | PROGESTERONE | NuCare Pharmaceuticals,Inc. | 4884017f-3314-cd26-e063-6294a90a4e7e | 2026-01-16 | Boxed warning, Warnings, Adverse reactions | PROGESTERONE |
| Progesterone | PROGESTERONE | NuCare Pharmaceuticals, Inc. | 4874ee1b-f661-05f7-e063-6394a90a2b8b | 2026-01-16 | Boxed warning, Warnings, Adverse reactions | PROGESTERONE |
| Progesterone 1538 | PROGESTERONE | Professional Complementary Health Formulas | a5b8449e-ae6f-48c1-8b71-2dd3c5332cc1 | 2026-01-08 | Warnings | PROGESTERONE |
| Progesterone vaginal insert | PROGESTERONE | XIROMED, LLC | 473ab609-5b9e-3cb8-68d5-4a459a2ea6c1 | 2026-01-06 | Warnings, Adverse reactions | PROGESTERONE |
| Progesterone | PROGESTERONE | Northwind Health Company, LLC | fcebe343-18ac-d4cd-e053-6294a90a72d5 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | PROGESTERONE |
| Progesterone | PROGESTERONE | Direct_Rx | 462ae686-7264-4852-e063-6294a90aae98 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | PROGESTERONE |
| BUNUSS Phyto-Pro Skin Cream | PROGESTERONE | Jiashen International Trade Limited | 44e1ec89-e2ea-d438-e063-6294a90a41f4 | 2025-12-01 | Warnings | PROGESTERONE |
| PROGESTERONE | PROGESTERONE | NuCare Pharmaceuticals,Inc. | 0b3da881-4720-cdee-e063-6394a90aee99 | 2025-11-03 | Boxed warning, Warnings, Adverse reactions | PROGESTERONE |
| PROGESTERONE | PROGESTERONE | Preferred Pharmaceuticals Inc. | 41c9546c-a854-4395-9506-d1be61f4e60f | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | PROGESTERONE |
| Progesterone | PROGESTERONE | Preferred Pharmaceuticals Inc. | c768aead-153b-42f3-bb4d-b06e30ebad80 | 2025-09-05 | Boxed warning, Warnings, Adverse reactions | PROGESTERONE |
| P25 Progesterone Cream | PROGESTERONE | SHYNE BRANDS | c47169b7-1b6a-2ad0-e053-2995a90a0b19 | 2025-06-01 | Warnings | PROGESTERONE |
| P75 Lav Progesterone Cream | PROGESTERONE | SHYNE BRANDS | c4711337-7c1f-3556-e053-2a95a90a7b82 | 2025-06-01 | Warnings | PROGESTERONE |
| P50 Progesterone Cream | PROGESTERONE | SHYNE BRANDS | c47121df-6c04-b273-e053-2a95a90aa549 | 2025-06-01 | Warnings | PROGESTERONE |
| Progesterone | PROGESTERONE | BioActive Nutritional, Inc. | 0de91238-dacc-4a5c-86d8-ad94024b2c95 | 2025-05-20 | Warnings | PROGESTERONE |
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 |
|---|---|---|---|---|---|
| 55566-9400 | Ferring Pharmaceuticals Inc. | progesterone | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-9400 | Ferring Pharmaceuticals Inc. | progesterone | Ferring Pharmaceuticals Inc. | NDA | Current |