Home Applications 212279 Application 212279
Type NDA
Sponsor GISKIT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EXEM FOAM KIT AIR POLYMER-TYPE A FOAM;INTRAUTERINE 10ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N212279-001 EXEM FOAM KIT AIR POLYMER-TYPE A 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 N212279-001 9849199 2036-02-11 Drug product 2019-12-10
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.
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 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD 2019-11-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 117 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 301d65b070ca…
Observed Orange Book exclusivity 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ExEm Foam AIR POLYMER-TYPE A INTRAUTERINE FOAM GISKIT PHARMA B.V. b8cb3e4d-ed22-4e88-abca-508c794b4b91 2023-11-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 212279 application number: NDA212279 ndc (product): 73254-310
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73254-310 ExEm Foam Air Polymer-Type A Intrauterine Foam GISKIT B.V. NDA Current 73254-310 ExEm Foam Air Polymer-Type A Intrauterine Foam GISKIT B.V. NDA Current 73254-310 ExEm Foam Air Polymer-Type A Intrauterine Foam GISKIT PHARMA B.V. NDA Current 73254-310 ExEm Foam Air Polymer-Type A Intrauterine Foam GISKIT PHARMA B.V. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 61125 ORIG 2019-12-03 60803 ORIG 2019-11-12 60798 ORIG 2019-11-08