Home Applications 070345 Application 070345
Type ANDA
Sponsor MYLAN PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLURAZEPAM HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE CAPSULE;ORAL 30MG No Yes 002 FLURAZEPAM HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE CAPSULE;ORAL 15MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070345-001 FLURAZEPAM HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 A070345-002 FLURAZEPAM HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 1 of 3 · 86 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 2026-09-14 22:38:34 2026-08 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL RS 1985-11-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL 1985-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL RS 1985-11-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL 1985-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL RS 1985-11-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL 1985-11-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL RS 1985-11-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL 1985-11-27 74a2ff9319b5…
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.
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 0378-4415 Flurazepam Hydrochloride flurazepam hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-4415 Flurazepam Hydrochloride flurazepam hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-4415 Flurazepam Hydrochloride flurazepam hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-4415 Flurazepam Hydrochloride flurazepam hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-4430 Flurazepam Hydrochloride flurazepam hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-4430 Flurazepam Hydrochloride flurazepam hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-4430 Flurazepam Hydrochloride flurazepam hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-4430 Flurazepam Hydrochloride flurazepam hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 55289-038 Flurazepam Hydrochloride flurazepam hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-038 Flurazepam Hydrochloride flurazepam hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-038 Flurazepam Hydrochloride flurazepam hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-038 Flurazepam Hydrochloride flurazepam hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current