Home Applications 007337 Application 007337
Type NDA
Sponsor ENDO PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 005 PERCODAN-DEMI ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE TABLET;ORAL 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 006 PERCODAN ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE TABLET;ORAL 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 007 PERCODAN ASPIRIN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;4.8355MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N007337-005 PERCODAN-DEMI ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 N007337-006 PERCODAN ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 N007337-007 PERCODAN ASPIRIN; OXYCODONE HYDROCHLORIDE 325MG;4.8355MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-08-05
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.
Product history page 2 of 4 · 132 observed 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 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N007337-006 PERCODAN 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N007337-006 PERCODAN 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N007337-006 PERCODAN 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N007337-006 PERCODAN 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N007337-006 PERCODAN 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG TABLET / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N007337-006 PERCODAN 325MG;4.5MG;0.38MG TABLET / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG TABLET / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N007337-006 PERCODAN 325MG;4.5MG;0.38MG TABLET / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N007337-006 PERCODAN 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N007337-006 PERCODAN 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N007337-006 PERCODAN 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N007337-006 PERCODAN 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N007337-006 PERCODAN 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N007337-006 PERCODAN 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N007337-007 PERCODAN 325MG;4.8355MG TABLET / ORAL AA RLD, RS 2005-08-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N007337-005 PERCODAN-DEMI 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N007337-006 PERCODAN 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL Approved before 1982 c0c555d07b60…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.