Home Applications 018708 Application 018708
Type NDA
Sponsor GALT PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DORAL QUAZEPAM TABLET;ORAL 15MG Yes Yes 003 DORAL QUAZEPAM TABLET;ORAL 7.5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N018708-001 DORAL QUAZEPAM 15MG TABLET / ORAL RLD, RS 1985-12-27 N018708-003 DORAL QUAZEPAM 7.5MG TABLET / ORAL 1987-02-26
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N018708-001 7608616 2028-06-03 U-1012 N018708-003 7608616 2028-06-03 U-1012
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 · 88 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 2026-10-15 13:18:30 2026-09 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018708-001 DORAL 15MG TABLET / ORAL RLD, RS 1985-12-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018708-003 DORAL 7.5MG TABLET / ORAL 1987-02-26 4b0b4de00fa7…
Observed Orange Book patent history# Patent history page 2 of 3 · 88 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Quazepam QUAZEPAM Atland Pharmaceuticals, LLC f7d63f3f-5303-48ab-bce2-35fd62c45799 2025-10-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018708 application number: NDA018708 ndc (product): 71993-265
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 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-1474 Quazepam QUAZEPAM A-S Medication Solutions LLC NDA Current 61825-165 Doral Quazepam Galt Pharmaceuticals LLC NDA Current 61825-165 DORAL Quazepam Galt Pharmaceuticals, LLC NDA Current 61825-165 DORAL Quazepam Galt Pharmaceuticals, LLC NDA Current 61825-165 DORAL Quazepam Galt Pharmaceuticals, LLC NDA Current 61825-165 DORAL Quazepam Galt Pharmaceuticals, LLC NDA Current 61825-165 DORAL Quazepam Galt Pharmaceuticals, LLC NDA Current 61825-165 DORAL Quazepam Galt Pharmaceuticals, LLC NDA Current 61825-165 DORAL Quazepam Galt Pharmaceuticals, LLC NDA Current 61825-165 DORAL Quazepam Galt Pharmaceuticals, LLC NDA Current 71993-265 Quazepam Quazepam Atland Pharmaceuticals, LLC NDA Current 71993-265 Quazepam Quazepam Atland Pharmaceuticals, LLC NDA Current 71993-265 Quazepam Quazepam Atland Pharmaceuticals, LLC NDA Current 71993-265 Quazepam Quazepam Atland Pharmaceuticals, LLC NDA Current 71993-265 Quazepam Quazepam Atland Pharmaceuticals, LLC NDA Current 71993-265 Quazepam Quazepam Atland Pharmaceuticals, LLC NDA Current 71993-265 Quazepam Quazepam Atland Pharmaceuticals, LLC NDA Current 71993-265 Quazepam Quazepam Atland Pharmaceuticals, LLC NDA Current 71993-265 Quazepam Quazepam Atland Pharmaceuticals, LLC NDA Current 71993-265 Quazepam Quazepam Atland Pharmaceuticals, LLC NDA Current