Application 050168

Type: NDA
Sponsor: MONARCH PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	CORTISPORIN	BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	OINTMENT;TOPICAL	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	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
N050168-002	CORTISPORIN	BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD	1984-05-04

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	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1984-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1984-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1984-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1984-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1984-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1984-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1984-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1984-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1984-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1984-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1984-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD, RS	1984-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD, RS	1984-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD, RS	1984-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD, RS	1984-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD, RS	1984-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD, RS	1984-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD, RS	1984-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD, RS	1984-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050168-002	CORTISPORIN	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM	OINTMENT / TOPICAL	RLD	1984-05-04	`e64feba35796…`

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61570-031	CORTISPORIN	neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-031	CORTISPORIN	neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83086	SUPPL	2025-08-12
83075	SUPPL	2025-08-11
17808	SUPPL	2003-12-02
7708	SUPPL	2003-11-28