Home Applications 210723 Application 210723
Type ANDA
Sponsor AM REGENT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE SOLUTION;INTRAMUSCULAR 250MG/ML (250MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog .
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 table 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 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 ea99ee380514…2023-01-26 05:58 UTC 2023-01 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210723-001 HYDROXYPROGESTERONE CAPROATE 250MG/ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP 2018-06-21 cb3db0bc1861…
Observed Orange Book normalized TE history# 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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0517-1767 Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate American Regent, Inc. ANDA Current 0517-1767 Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate American Regent, Inc. ANDA Current 0517-1767 Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate American Regent, Inc. ANDA Current 0517-1791 Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate American Regent, Inc. ANDA Current 0517-1791 Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate American Regent, Inc. ANDA Current 0517-1791 Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate American Regent, Inc. ANDA Current 69238-1797 Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate Amneal Pharmaceuticals of NY LLC ANDA Current 69238-1797 Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate Amneal Pharmaceuticals of NY LLC ANDA Current 69238-1797 Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate Amneal Pharmaceuticals NY LLC ANDA Current 69238-1797 Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate Amneal Pharmaceuticals of NY LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 54815 ORIG 2018-07-06