Home Applications 202813 Application 202813
Type NDA
Sponsor TEVA BRANDED PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QNASL BECLOMETHASONE DIPROPIONATE AEROSOL, METERED;NASAL 0.08MG/ACTUATION Yes Yes 002 QNASL BECLOMETHASONE DIPROPIONATE AEROSOL, METERED;NASAL 0.04MG/ACTUATION Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N202813-001 QNASL BECLOMETHASONE DIPROPIONATE 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 N202813-002 QNASL BECLOMETHASONE DIPROPIONATE 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17
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 N202813-001 10188811 2031-10-21 Drug product 2019-02-21 N202813-002 10188811 2031-10-21 Drug product 2019-02-21
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 1 of 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202813-001 QNASL 0.08MG/ACTUATION AEROSOL, METERED / NASAL RLD, RS 2012-03-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202813-002 QNASL 0.04MG/ACTUATION AEROSOL, METERED / NASAL RLD 2014-12-17 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 4 · 158 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202813-001 10188811 2031-10-21 Drug product 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202813-002 10188811 2031-10-21 Drug product 2019-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202813-001 10188811 2031-10-21 Drug product 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202813-002 10188811 2031-10-21 Drug product 2019-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202813-001 7780038 2027-01-24 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202813-001 10188811 2031-10-21 Drug product 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202813-002 7780038 2027-01-24 Drug product 2015-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202813-002 10188811 2031-10-21 Drug product 2019-02-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202813-001 7780038 2027-01-24 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202813-001 10188811 2031-10-21 Drug product 2019-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202813-002 7780038 2027-01-24 Drug product 2015-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202813-002 10188811 2031-10-21 Drug product 2019-02-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202813-001 7780038 2027-01-24 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202813-001 10188811 2031-10-21 Drug product 2019-02-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202813-002 7780038 2027-01-24 Drug product 2015-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202813-002 10188811 2031-10-21 Drug product 2019-02-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202813-001 7780038 2027-01-24 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202813-001 10188811 2031-10-21 Drug product 2019-02-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202813-002 7780038 2027-01-24 Drug product 2015-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202813-002 10188811 2031-10-21 Drug product 2019-02-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202813-001 7780038 2027-01-24 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202813-001 10188811 2031-10-21 Drug product 2019-02-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202813-002 7780038 2027-01-24 Drug product 2015-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202813-002 10188811 2031-10-21 Drug product 2019-02-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202813-001 7780038 2027-01-24 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202813-001 10188811 2031-10-21 Drug product 2019-02-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202813-002 7780038 2027-01-24 Drug product 2015-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202813-002 10188811 2031-10-21 Drug product 2019-02-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202813-001 7780038 2027-01-24 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202813-001 10188811 2031-10-21 Drug product 2019-02-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202813-002 7780038 2027-01-24 Drug product 2015-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202813-002 10188811 2031-10-21 Drug product 2019-02-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202813-001 7780038 2027-01-24 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202813-001 10188811 2031-10-21 Drug product 2019-02-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202813-002 7780038 2027-01-24 Drug product 2015-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202813-002 10188811 2031-10-21 Drug product 2019-02-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202813-001 7780038 2027-01-24 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202813-001 10188811 2031-10-21 Drug product 2019-02-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202813-002 7780038 2027-01-24 Drug product 2015-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202813-002 10188811 2031-10-21 Drug product 2019-02-21 79d66fd596c7…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59310-206 QNASL Beclomethasone Dipropionate Teva Respiratory, LLC NDA Current 59310-206 QNASL Beclomethasone Dipropionate Teva Respiratory, LLC NDA Current 59310-210 QNASL Beclomethasone Dipropionate Teva Respiratory, LLC NDA Current 59310-210 QNASL Beclomethasone Dipropionate Teva Respiratory, LLC NDA Current 59310-406 QNASL Beclomethasone Dipropionate Teva Respiratory, LLC NDA Current 59310-406 QNASL Beclomethasone Dipropionate Teva Respiratory, LLC NDA Current 59310-406 QNASL Beclomethasone Dipropionate Teva Respiratory, LLC NDA Current 59310-406 QNASL Beclomethasone Dipropionate Teva Respiratory, LLC NDA Current 59310-406 QNASL Beclomethasone Dipropionate Teva Respiratory, LLC NDA Current 59310-410 QNASL Beclomethasone dipropionate Teva Respiratory, LLC NDA Current 59310-410 QNASL Beclomethasone dipropionate Teva Respiratory, LLC NDA Current 59310-410 QNASL Beclomethasone dipropionate Teva Respiratory, LLC NDA Current 59310-410 QNASL Beclomethasone dipropionate Teva Respiratory, LLC NDA Current 59310-410 QNASL Beclomethasone dipropionate Teva Respiratory, LLC NDA Current