Application 050218

Type: NDA
Sponsor: MONARCH PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CORTISPORIN	HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	CREAM;TOPICAL	0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	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
N050218-001	CORTISPORIN	HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1985-08-09

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	N050218-001	CORTISPORIN	0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	CREAM / TOPICAL	RLD	1985-08-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050218-001	CORTISPORIN	0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	CREAM / TOPICAL	RLD	1985-08-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050218-001	CORTISPORIN	0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	CREAM / TOPICAL	RLD	1985-08-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050218-001	CORTISPORIN	0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1985-08-09	`a50c72e98297…`

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61570-032	CORTISPORIN	neomycin sulfate, polymyxin B sulfate, and hydrocortisone acetate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-032	CORTISPORIN	neomycin sulfate, polymyxin B sulfate, and hydrocortisone acetate	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83087	SUPPL	2025-08-12
83076	SUPPL	2025-08-11
29997	SUPPL	2004-06-02