Application 050108

Type: NDA
Sponsor: PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	COLY-MYCIN M	COLISTIMETHATE SODIUM	INJECTABLE;INJECTION	EQ 150MG BASE/VIAL	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
N050108-002	COLY-MYCIN M	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982

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	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050108-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050108-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050108-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050108-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050108-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050108-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050108-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050108-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050108-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050108-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050108-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050108-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050108-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050108-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050108-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050108-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050108-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050108-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050108-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050108-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050108-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050108-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050108-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050108-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050108-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050108-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050108-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050108-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050108-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050108-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050108-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050108-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050108-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050108-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050108-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050108-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050108-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050108-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050108-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050108-002	AP	1	`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
Coly-Mycin M	COLISTIMETHATE	Par Health USA, LLC	6d6e13e2-dc33-4b7b-84d0-66146a57c552	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050108 application number: NDA050108 ndc (product): 42023-107

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-107	Coly-Mycin	colistimethate	Par Pharmaceutical, Inc.	NDA	Current
42023-107	Coly-Mycin	colistimethate	Par Pharmaceutical, Inc.	NDA	Current
42023-131	Colistimethate	colistimethate sodium	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82753	SUPPL	2025-07-08
82742	SUPPL	2025-07-08
48057	SUPPL	2017-04-18
48051	SUPPL	2017-04-18
29980	SUPPL	2013-03-08
17800	SUPPL	2013-03-08
17799	SUPPL	2009-06-07
7693	SUPPL	2009-05-19
44199	ORIG	2007-06-29
7692	SUPPL	2006-01-20
38913	SUPPL	2006-01-13
29979	SUPPL	2004-06-01