Application 216903

Type: NDA
Sponsor: AZURITY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREVDUO	GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE	SOLUTION;INTRAVENOUS	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	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
N216903-001	PREVDUO	GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-02-23

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N216903-001	10456354	2038-10-25	Drug product	2023-02-24
N216903-001	11110054	2038-10-25	Drug product	2023-02-24
N216903-001	11938217	2038-10-25	Drug product	2024-03-28
N216903-001	12151020	2038-10-25	Drug product	2024-11-27
N216903-001	12383491	2038-10-25	Drug product	2025-08-21

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-23	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216903-001	PREVDUO	0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-02-23	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216903-001	10456354	2038-10-25	Drug product	2023-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216903-001	11110054	2038-10-25	Drug product	2023-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216903-001	11938217	2038-10-25	Drug product	2024-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216903-001	12151020	2038-10-25	Drug product	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216903-001	12383491	2038-10-25	Drug product	2025-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216903-001	10456354	2038-10-25	Drug product	2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216903-001	11110054	2038-10-25	Drug product	2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216903-001	11938217	2038-10-25	Drug product	2024-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216903-001	12151020	2038-10-25	Drug product	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216903-001	12383491	2038-10-25	Drug product	2025-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216903-001	10456354	2038-10-25	Drug product	2023-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216903-001	11110054	2038-10-25	Drug product	2023-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216903-001	11938217	2038-10-25	Drug product	2024-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216903-001	12151020	2038-10-25	Drug product	2024-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216903-001	10456354	2038-10-25	Drug product	2023-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216903-001	11110054	2038-10-25	Drug product	2023-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216903-001	11938217	2038-10-25	Drug product	2024-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216903-001	12151020	2038-10-25	Drug product	2024-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216903-001	10456354	2038-10-25	Drug product	2023-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216903-001	11110054	2038-10-25	Drug product	2023-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216903-001	11938217	2038-10-25	Drug product	2024-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216903-001	12151020	2038-10-25	Drug product	2024-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216903-001	10456354	2038-10-25	Drug product	2023-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216903-001	11110054	2038-10-25	Drug product	2023-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216903-001	11938217	2038-10-25	Drug product	2024-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216903-001	12151020	2038-10-25	Drug product	2024-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216903-001	10456354	2038-10-25	Drug product	2023-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216903-001	11110054	2038-10-25	Drug product	2023-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216903-001	11938217	2038-10-25	Drug product	2024-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216903-001	12151020	2038-10-25	Drug product	2024-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216903-001	10456354	2038-10-25	Drug product	2023-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216903-001	11110054	2038-10-25	Drug product	2023-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216903-001	11938217	2038-10-25	Drug product	2024-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216903-001	10456354	2038-10-25	Drug product	2023-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216903-001	11110054	2038-10-25	Drug product	2023-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216903-001	11938217	2038-10-25	Drug product	2024-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216903-001	10456354	2038-10-25	Drug product	2023-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216903-001	11110054	2038-10-25	Drug product	2023-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216903-001	11938217	2038-10-25	Drug product	2024-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216903-001	10456354	2038-10-25	Drug product	2023-02-24	`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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREVDUO	NEOSTIGMINE METHYLSULFATE AND GLYCOPYRROLATE	Endo USA	dd8ad38f-247b-4948-a13c-8f3a4921b4f1	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216903 application number: NDA216903

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74070	ORIG	2023-04-26
73605	ORIG	2023-02-24
73604	ORIG	2023-02-24