Home Applications 021393 Application 021393
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ADVIL PM DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN CAPSULE;ORAL 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021393-001 ADVIL PM DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL RLD, RS 2005-12-21
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 2 · 44 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 2022-10-28 04:53 UTC 2022-10 N021393-001 ADVIL PM 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL RLD, RS 2005-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021393-001 ADVIL PM 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL RLD, RS 2005-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021393-001 ADVIL PM 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL RLD, RS 2005-12-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021393-001 ADVIL PM 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL RLD, RS 2005-12-21 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 ea99ee380514…2023-01-26 05:58 UTC 2023-01 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021393-001 8883849 2022-01-17 U-1618 2014-12-09 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021393-001 9155718 2022-01-17 Drug product 2015-11-10 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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0573-0167 ADVIL PM diphenhydramine HCl, ibuprofen Pfizer Consumer Healthcare NDA Current 0573-0167 ADVIL PM diphenhydramine HCl, ibuprofen GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0573-0167 ADVIL PM diphenhydramine HCl, ibuprofen GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0573-0167 ADVIL PM diphenhydramine HCl, ibuprofen GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current