Application 065022

Type: ANDA
Sponsor: PERRIGO CO TENNESSEE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	BACITRACIN ZINC; POLYMYXIN B SULFATE	OINTMENT;OPHTHALMIC	500 UNITS/GM;10,000 UNITS/GM	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	BACITRACIN ZINC; POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC			2002-02-27

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065022-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	2002-02-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065022-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065022-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065022-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065022-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065022-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065022-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065022-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065022-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065022-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065022-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065022-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065022-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065022-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065022-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065022-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065022-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065022-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065022-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065022-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065022-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065022-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065022-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065022-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065022-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065022-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065022-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065022-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065022-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065022-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065022-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065022-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065022-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065022-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065022-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065022-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065022-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065022-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065022-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065022-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065022-001	AT	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
polycin	BACITRACIN ZINC AND POLYMYXIN B SULFATES	NuCare Pharmaceuticals,Inc.	5d55e918-98a0-4989-e053-2a91aa0a9ad7	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065022 application number: ANDA065022 ndc (product): 66267-925

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0273	Bacitracin Zinc and Polymyxin B Sulfate	Bacitracin Zinc and Polymyxin B Sulfate	E. FOUGERA & CO., A division of Nycomed US Inc.	ANDA	Current
0574-4021	polycin	bacitracin zinc and polymyxin b sulfates	Padagis US LLC	ANDA	Current
0574-4021	polycin	bacitracin zinc and polymyxin b sulfates	Paddock Laboratories, LLC	ANDA	Current
50090-1653	polycin	bacitracin zinc and polymyxin b sulfates	A-S Medication Solutions	ANDA	Current
50090-1653	polycin	bacitracin zinc and polymyxin b sulfates	A-S Medication Solutions	ANDA	Current
53002-9270	polycin	bacitracin zinc and polymyxin b sulfates	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9270	polycin	bacitracin zinc and polymyxin b sulfates	RPK Pharmaceuticals, Inc.	ANDA	Current
61919-111	POLYCIN	bacitracin zinc and polymyxin b sulfates	DIRECT RX	ANDA	Current
61919-111	POLYCIN	bacitracin zinc and polymyxin b sulfates	DIRECT RX	ANDA	Current
66267-925	polycin	bacitracin zinc and polymyxin b sulfates	NuCare Pharmaceuticals,In	ANDA	Current
66267-925	polycin	bacitracin zinc and polymyxin b sulfates	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-925	polycin	bacitracin zinc and polymyxin b sulfates	NuCare Pharmaceuticals,Inc.	ANDA	Current