Application 018680

Type: NDA
Sponsor: COOPERSURGICAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PARAGARD T 380A	COPPER	INTRAUTERINE DEVICE;INTRAUTERINE	309MG/COPPER	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018680-001	PARAGARD T 380A	COPPER	309MG/COPPER	SYSTEM / INTRAUTERINE		RLD, RS	1984-11-15

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N018680-001	D-193	2027-06-28

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N018680-001	PARAGARD T 380A	309MG/COPPER	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	1984-11-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018680-001	PARAGARD T 380A	309MG/COPPER	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	1984-11-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018680-001	PARAGARD T 380A	309MG/COPPER	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	1984-11-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018680-001	PARAGARD T 380A	309MG/COPPER	SYSTEM / INTRAUTERINE	RLD, RS	1984-11-15	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N018680-001	D-193	2027-06-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018680-001	D-193	2027-06-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018680-001	D-193	2027-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018680-001	D-193	2027-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018680-001	D-193	2027-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018680-001	D-193	2027-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018680-001	D-193	2027-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018680-001	D-193	2027-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018680-001	D-193	2027-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018680-001	D-193	2027-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018680-001	D-193	2027-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018680-001	D-193	2027-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018680-001	D-193	2027-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018680-001	D-193	2027-06-28	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018680-001	D-193	2027-06-28	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ParaGard T 380A	COPPER	CooperSurgical, Inc.	3c420b53-c95e-46af-aebd-73741be58391	2024-06-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018680 application number: NDA018680
ParaGard T 380A	COPPER	CooperSurgical, Inc.	5ea7ce51-b87a-485e-b841-99466a07a4b2	2019-09-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018680 application number: NDA018680 ndc (product): 59365-5128

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51285-204	ParaGard T 380A	Copper	Teva Women's Health, Inc.	NDA	Current
51285-204	ParaGard T 380A	Copper	Teva Women's Health, Inc.	NDA	Current
59365-5128	ParaGard T 380A	Copper	CooperSurgical, Inc.	NDA	Current
59365-5128	ParaGard T 380A	Copper	CooperSurgical, Inc.	NDA	Current
59365-5128	ParaGard T 380A	Copper	CooperSurgical, Inc.	NDA	Current
59365-5128	ParaGard T 380A	Copper	CooperSurgical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78948	SUPPL	2024-09-16
82760	SUPPL	2024-07-01
59935	SUPPL	2019-09-11
59934	SUPPL	2019-09-11
59930	SUPPL	2019-09-06
59928	SUPPL	2019-09-06
33555	SUPPL	2013-06-18
1020	SUPPL	2013-06-13
20148	ORIG	2011-02-15
15088	SUPPL	2005-09-08
11275	SUPPL	2005-09-08
1019	SUPPL	2003-05-29
33554	SUPPL	2003-04-30