Home Applications 019886 Application 019886
Type NDA
Sponsor GD SEARLE LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SYNAREL NAFARELIN ACETATE SPRAY, METERED;NASAL EQ 0.2MG BASE/SPRAY Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019886-001 SYNAREL NAFARELIN ACETATE EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13
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 2 · 41 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 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 cb3db0bc1861…
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 Synarel NAFARELIN ACETATE Pfizer Laboratories Div Pfizer Inc d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6 2026-03-05 Warnings, Adverse reactions Exact identifier application applno (NDA): 019886 application number: NDA019886 ndc (product): 0025-0166
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0025-0166 Synarel nafarelin acetate Pfizer Laboratories Div Pfizer Inc NDA Current 0025-0166 Synarel nafarelin acetate Pfizer Laboratories Div Pfizer Inc NDA Current 0025-0166 Synarel nafarelin acetate Pfizer Laboratories Div Pfizer Inc NDA Current 0025-0166 Synarel nafarelin acetate G.D. Searle LLC Division of Pfizer Inc NDA Current