Application 210724
- Type
- ANDA
- Sponsor
- AM REGENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROXYPROGESTERONE CAPROATE | HYDROXYPROGESTERONE CAPROATE | SOLUTION;INTRAMUSCULAR | 1250MG/5ML (250MG/ML) | No | No |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A210724-001 | HYDROXYPROGESTERON CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | AP1 | 2019-08-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A210724-001 | HYDROXYPROGESTERON CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | AP1 | 2019-08-09 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A210724-001 | HYDROXYPROGESTERON CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | AP1 | 2019-08-09 | b00525d2431f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210724-001 | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | 2019-08-09 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A210724-001 | AP1 | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A210724-001 | AP1 | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A210724-001 | AP1 | 1 | b00525d2431f… |
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 |
|---|---|---|---|---|---|---|
| Hydroxyprogesterone Caproate | HYDROXYPROGESTERONE CAPROATE | Eugia US LLC | 687bcf42-f437-42c7-8909-a91f621f55df | 2026-06-12 | Warnings, Adverse reactions | Hydroxyprogesterone Caproate HYDROXYPROGESTERONE CAPROATE |