Application 050586

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRED-G	GENTAMICIN SULFATE; PREDNISOLONE ACETATE	SUSPENSION/DROPS;OPHTHALMIC	EQ 0.3% BASE;1%	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
N050586-001	PRED-G	GENTAMICIN SULFATE; PREDNISOLONE ACETATE	EQ 0.3% BASE;1%	SUSPENSION/DROPS / OPHTHALMIC		RLD	1988-06-10

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	N050586-001	PRED-G	EQ 0.3% BASE;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1988-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050586-001	PRED-G	EQ 0.3% BASE;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1988-06-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050586-001	PRED-G	EQ 0.3% BASE;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1988-06-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050586-001	PRED-G	EQ 0.3% BASE;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD	1988-06-10	`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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-0106	PRED-G	gentamicin, prednisolone acetate	Allergan, Inc.	NDA	Current
0023-0106	PRED-G	gentamicin, prednisolone acetate	Allergan, Inc.	NDA	Current
0023-0106	PRED-G	gentamicin, prednisolone acetate	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54559	SUPPL	2018-06-14
54494	SUPPL	2018-06-11
47690	SUPPL	2017-03-24
47624	SUPPL	2017-03-21
30122	SUPPL	2006-01-19
7849	SUPPL	2006-01-19
39009	SUPPL	2006-01-05
17904	SUPPL	2006-01-05