Application 018986

Type: NDA
Sponsor: MERIDIAN MEDCL TECHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRALIDOXIME CHLORIDE	PRALIDOXIME CHLORIDE	INJECTABLE;INJECTION	300MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	PRALIDOXIME CHLORIDE	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR		RLD	1983-04-26

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018986-001	PRALIDOXIME CHLORIDE	300MG/ML	INJECTABLE / INJECTION	RLD, RS	1983-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018986-001	PRALIDOXIME CHLORIDE	300MG/ML	INJECTABLE / INJECTION	RLD, RS	1983-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018986-001	PRALIDOXIME CHLORIDE	300MG/ML	INJECTABLE / INJECTION	RLD, RS	1983-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018986-001	PRALIDOXIME CHLORIDE	300MG/ML	INJECTABLE / INJECTION	RLD, RS	1983-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018986-001	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	600MG/2ML (300MG/ML)	SOLUTION / INTRAMUSCULAR	RLD	1983-04-26	`e64feba35796…`

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
Protopam Chloride	PRALIDOXIME CHLORIDE	Baxter Healthcare Corporation	2741d8fd-51c2-46be-880b-99f2b20a6137	2026-04-01	Warnings, Adverse reactions	Name fallback generic name: PRALIDOXIME CHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11704-251	Pralidoxime Chloride	Pralidoxime Chloride	Meridian Medical Technologies, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40840	ORIG	2003-06-17