Application 050065

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	MAXITROL	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	OINTMENT;OPHTHALMIC	0.1%;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
N050065-002	MAXITROL	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N050065-002	AT

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	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N050065-002	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050065-002	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050065-002	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050065-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050065-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050065-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050065-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050065-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050065-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050065-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050065-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050065-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050065-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050065-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050065-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050065-002	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050065-002	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050065-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050065-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050065-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050065-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050065-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050065-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050065-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050065-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050065-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050065-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050065-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050065-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050065-002	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050065-002	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050065-002	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050065-002	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050065-002	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050065-002	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050065-002	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050065-002	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050065-002	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050065-002	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050065-002	AT	1	`3a93d1ddd44b…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	a7e55c43-4345-4710-e053-2995a90aeee7	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065 ndc (product): 68071-5281
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Sandoz Inc	7f2e3c46-9f39-45e7-99a9-64cc4f6f649d	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065 ndc (product): 61314-631
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	A-S Medication Solutions	6791e6c3-514d-4b98-8887-ca2b894576b5	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065 ndc (product): 50090-4435
MAXITROL	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Sandoz Inc	5776c435-ac60-49b6-8db1-23a3012b9155	2023-12-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065
MAXITROL	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Novartis Pharmaceuticals Corporation	22c6d2db-85af-4a3b-a014-80d901a86717	2023-06-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065 ndc (product): 0078-0771
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Proficient Rx LP	aa7b8a3f-06dd-4190-96a5-f86195bd2197	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065 ndc (product): 71205-330

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0631	MAXITROL	neomycin sulfate, polymyxin b sulfate and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0631	MAXITROL	neomycin sulfate, polymyxin b sulfate and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0631	MAXITROL	neomycin sulfate, polymyxin b sulfate and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0078-0771	MAXITROL	neomycin sulfate, polymyxin b sulfate and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0771	MAXITROL	neomycin sulfate, polymyxin b sulfate and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0771	MAXITROL	neomycin sulfate, polymyxin b sulfate and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
50090-4435	Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin and Polymyxin B Sulfates and Dexamethasone	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
61314-631	Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin and Polymyxin B Sulfates and Dexamethasone	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-631	Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin and Polymyxin B Sulfates and Dexamethasone	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-631	Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin and Polymyxin B Sulfates and Dexamethasone	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
68071-5281	Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin and Polymyxin B Sulfates and Dexamethasone	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-5281	Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin and Polymyxin B Sulfates and Dexamethasone	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
71205-330	Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin and Polymyxin B Sulfates and Dexamethasone	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
71205-330	Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin and Polymyxin B Sulfates and Dexamethasone	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
72189-038	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Direct_Rx	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67536	SUPPL	2021-05-18
67499	SUPPL	2021-05-17
50870	SUPPL	2017-12-27
50761	SUPPL	2017-12-19
48038	SUPPL	2017-04-14
48002	SUPPL	2017-04-13
38911	SUPPL	2004-07-21
29977	SUPPL	2004-07-21
17796	SUPPL	2004-07-21
7690	SUPPL	2004-07-21
38910	SUPPL	2003-07-28
29976	SUPPL	2003-07-28
17795	SUPPL	2003-07-28
7689	SUPPL	2003-07-28