Home Applications 014713 Application 014713
Type NDA
Sponsor SCHERING Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 ETRAFON-A AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE TABLET;ORAL 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 004 ETRAFON 2-25 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE TABLET;ORAL 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 006 ETRAFON-FORTE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE TABLET;ORAL 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 007 ETRAFON 2-10 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE TABLET;ORAL 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N014713-002 ETRAFON-A AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 N014713-004 ETRAFON 2-25 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 N014713-006 ETRAFON-FORTE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 N014713-007 ETRAFON 2-10 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982
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 5 of 5 · 176 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 N014713-002 ETRAFON-A 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N014713-004 ETRAFON 2-25 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N014713-006 ETRAFON-FORTE 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N014713-007 ETRAFON 2-10 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N014713-002 ETRAFON-A 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N014713-004 ETRAFON 2-25 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N014713-006 ETRAFON-FORTE 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N014713-007 ETRAFON 2-10 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N014713-002 ETRAFON-A 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N014713-004 ETRAFON 2-25 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N014713-006 ETRAFON-FORTE 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N014713-007 ETRAFON 2-10 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N014713-002 ETRAFON-A 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N014713-004 ETRAFON 2-25 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N014713-006 ETRAFON-FORTE 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N014713-007 ETRAFON 2-10 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 44006 ORIG 2007-05-09 12072 SUPPL 2002-05-10 385 SUPPL 2002-05-10