Home Applications 076762 Application 076762
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOXAPINE SUCCINATE LOXAPINE SUCCINATE CAPSULE;ORAL EQ 5MG BASE No No 002 LOXAPINE SUCCINATE LOXAPINE SUCCINATE CAPSULE;ORAL EQ 10MG BASE No No 003 LOXAPINE SUCCINATE LOXAPINE SUCCINATE CAPSULE;ORAL EQ 25MG BASE No No 004 LOXAPINE SUCCINATE LOXAPINE SUCCINATE CAPSULE;ORAL EQ 50MG BASE 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 A076762-001 LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL 2004-11-01 A076762-002 LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL 2004-11-01 A076762-003 LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL 2004-11-01 A076762-004 LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL 2004-11-01
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 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 2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076762-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL 2004-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076762-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL 2004-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076762-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL 2004-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076762-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL 2004-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076762-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL 2004-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076762-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL 2004-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076762-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL 2004-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076762-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL 2004-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076762-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL 2004-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076762-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL 2004-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076762-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL 2004-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076762-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL 2004-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076762-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL 2004-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076762-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL 2004-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076762-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL 2004-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076762-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL 2004-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076762-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL 2004-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076762-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL 2004-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076762-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL 2004-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076762-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL 2004-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076762-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL 2004-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076762-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL 2004-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076762-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL 2004-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076762-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL 2004-11-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076762-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL 2004-11-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076762-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL 2004-11-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076762-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL 2004-11-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076762-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL 2004-11-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076762-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL 2004-11-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076762-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL 2004-11-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076762-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL 2004-11-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076762-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL 2004-11-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076762-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL 2004-11-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076762-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL 2004-11-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076762-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL 2004-11-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076762-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL 2004-11-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076762-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL 2004-11-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076762-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL 2004-11-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076762-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL 2004-11-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076762-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL 2004-11-01 4b0b4de00fa7…
Observed Orange Book normalized TE history# 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-7005 Loxapine loxapine Mylan Pharmaceuticals Inc. ANDA Current 0378-7010 Loxapine loxapine Mylan Pharmaceuticals Inc. ANDA Current 0378-7025 Loxapine loxapine Mylan Pharmaceuticals Inc. ANDA Current 0378-7050 Loxapine loxapine Mylan Pharmaceuticals Inc. ANDA Current 50090-3457 Loxapine loxapine A-S Medication Solutions ANDA Current 51079-901 Loxapine loxapine Mylan Institutional Inc. ANDA Current 51079-901 Loxapine loxapine Mylan Institutional Inc. ANDA Current 51079-902 Loxapine loxapine Mylan Institutional Inc. ANDA Current 51079-902 Loxapine loxapine Mylan Institutional Inc. ANDA Current 51079-903 Loxapine loxapine Mylan Institutional Inc. ANDA Current 70518-0995 Loxapine loxapine REMEDYREPACK INC. ANDA Current 70518-0995 Loxapine loxapine REMEDYREPACK INC. ANDA Current