Application 064065

Type: ANDA
Sponsor: BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OTICAIR	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	SUSPENSION/DROPS;OTIC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A064065-001	OTICAIR	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RS	1996-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064065-001	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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RS	1996-08-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064065-001	OTICAIR	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT		1996-08-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A064065-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064065-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064065-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064065-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064065-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064065-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064065-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064065-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064065-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064065-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064065-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064065-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064065-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064065-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064065-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064065-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064065-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064065-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064065-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064065-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064065-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064065-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064065-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064065-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064065-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064065-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064065-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064065-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064065-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064065-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064065-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064065-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064065-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064065-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064065-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064065-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064065-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064065-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064065-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064065-001	AT	1	`f41ea6bd6efb…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	f8dc2b6f-daf3-4a3a-b31f-b97e2f152eae	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064065 application number: ANDA064065 ndc (product): 68788-9924
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	A-S Medication Solutions	1185a82b-e731-456a-8fc1-d9f0fc1ab0bc	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064065 application number: ANDA064065 ndc (product): 50090-0431
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Bausch & Lomb Incorporated	b0ee85dd-5fe1-46a3-9bff-606e489d20b1	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064065 application number: ANDA064065 ndc (product): 24208-635
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	6296e2ed-336b-b9af-e053-2991aa0aae0c	2024-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064065 application number: ANDA064065 ndc (product): 68071-4229
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Proficient Rx LP	98042cef-2839-49d6-a7bd-a1d29c74430b	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064065 application number: ANDA064065 ndc (product): 63187-308

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 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24208-635	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	Bausch & Lomb Incorporated	ANDA	Current
24208-635	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	Bausch & Lomb Incorporated	ANDA	Current
49999-439	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
50090-0431	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	A-S Medication Solutions	ANDA	Current
50090-0431	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	A-S Medication Solutions	ANDA	Current
50090-0431	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	A-S Medication Solutions	ANDA	Current
50090-0431	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	A-S Medication Solutions	ANDA	Current
50436-0737	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	Unit Dose Services	ANDA	Current
52959-084	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	H.J. Harkins Company, Inc.	ANDA	Current
53002-9000	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9000	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	RPK Pharmaceuticals, Inc.	ANDA	Current
61919-662	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	DIRECT RX	ANDA	Current
61919-662	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	DIRECT RX	ANDA	Current
63187-308	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	Proficient Rx LP	ANDA	Current
63187-308	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	Proficient Rx LP	ANDA	Current
63187-308	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	Proficient Rx LP	ANDA	Current
66267-957	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-957	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4229	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4229	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4229	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9924	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9924	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9924	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9924	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0864	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	REMEDYREPACK INC.	ANDA	Current
76413-117	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	Central Texas Community Health Centers	ANDA	Current