Application 064028

Type: ANDA
Sponsor: AKORN

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 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
A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	BACITRACIN ZINC; POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC			1995-01-30

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064028-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064028-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064028-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064028-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064028-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064028-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064028-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064028-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064028-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064028-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064028-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064028-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064028-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064028-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064028-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064028-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064028-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064028-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064028-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064028-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064028-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064028-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064028-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064028-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064028-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064028-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064028-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064028-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bacitracin Zinc and Polymyxin B Sulfate	BACITRACIN ZINC AND POLYMYXIN B SULFATE	A-S Medication Solutions	51f6eac3-205e-4beb-8522-6ba2c593f350	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Bacitracin Zinc and Polymyxin B Sulfate
Bacitracin Zinc and Polymyxin B Sulfate	BACITRACIN ZINC AND POLYMYXIN B SULFATE	A-S Medication Solutions	19b4cfab-5927-47c5-a032-58ab2998d9c7	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Bacitracin Zinc and Polymyxin B Sulfate
Bacitracin Zinc and Polymyxin B Sulfate	BACITRACIN ZINC AND POLYMYXIN B SULFATE	NuCare Pharmaceuticals,Inc.	a73654f4-949d-3da4-e053-2995a90a1fc3	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Bacitracin Zinc and Polymyxin B Sulfate
Bacitracin Zinc and Polymyxin B Sulfate	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Bausch & Lomb Incorporated	1b317249-30eb-4415-8a1c-cfedb4ba3549	2024-10-18	Warnings, Adverse reactions	Name fallback brand name: Bacitracin Zinc and Polymyxin B Sulfate

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-238	AK-POLY-BAC	Bacitracin Zinc and Polymyxin B Sulfate	Akorn, Inc.	ANDA	Current
17478-238	AK-POLY-BAC	Bacitracin Zinc and Polymyxin B Sulfate	Akorn, Inc.	ANDA	Current
17478-238	AK-POLY-BAC	Bacitracin Zinc and Polymyxin B Sulfate	Akorn	ANDA	Current
21695-156	Bacitracin Zinc and Polymyxin B Sulfate	Bacitracin Zinc and Polymyxin B Sulfate	Rebel Distributors Corp.	ANDA	Current
50090-0447	AK-POLY-BAC	Bacitracin Zinc and Polymyxin B Sulfate	A-S Medication Solutions	ANDA	Current
61919-989	AK-POLY-BAC	AK-POLY-BAC	DIRECT RX	ANDA	Current
61919-989	AK-POLY-BAC	AK-POLY-BAC	DIRECT RX	ANDA	Current