Application 062447

Type: ANDA
Sponsor: PERRIGO CO TENNESSEE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERYTHROMYCIN	ERYTHROMYCIN	OINTMENT;OPHTHALMIC	0.5%	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A062447-001	ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26

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 · 42 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
2026-08-18 06:07:40	2026-07	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062447-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062447-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062447-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062447-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062447-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062447-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062447-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062447-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062447-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062447-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062447-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062447-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062447-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062447-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062447-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062447-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062447-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062447-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062447-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062447-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062447-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062447-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062447-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062447-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062447-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062447-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	84119a8f-78d1-2882-e053-2a91aa0a6faa	2024-06-14	Adverse reactions	Exact identifier application applno (ANDA): 062447 application number: ANDA062447 ndc (product): 68071-4803
erythromycin	ERYTHROMYCIN	Asclemed USA, Inc.	6186510d-62ca-4083-9895-8d028d71b510	2023-09-12	Adverse reactions	Exact identifier application applno (ANDA): 062447 application number: ANDA062447
erythromycin	ERYTHROMYCIN	A-S Medication Solutions	1df12239-6957-4b2c-9e65-e2154eafddd0	2023-02-04	Adverse reactions	Exact identifier application applno (ANDA): 062447 application number: ANDA062447 ndc (product): 50090-1958

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0574-4024	erythromycin	erythromycin	Paddock Laboratories, LLC	ANDA	Current
0574-4024	erythromycin	erythromycin	Padagis US LLC	ANDA	Current
50090-1958	erythromycin	erythromycin	A-S Medication Solutions	ANDA	Current
50090-1958	erythromycin	erythromycin	A-S Medication Solutions	ANDA	Current
68071-4803	erythromycin	erythromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4803	erythromycin	erythromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9393	erythromycin	erythromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9393	erythromycin	erythromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9393	erythromycin	erythromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9393	erythromycin	erythromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0392	erythromycin	erythromycin	REMEDYREPACK INC.	ANDA	Current
71205-265	erythromycin	erythromycin	Proficient Rx LP	ANDA	Current
71205-265	erythromycin	erythromycin	Proficient Rx LP	ANDA	Current
71205-265	erythromycin	erythromycin	Proficient Rx LP	ANDA	Current
71205-265	erythromycin	erythromycin	Proficient Rx LP	ANDA	Current
72189-036	ERYTHROMYCIN	ERYTHROMYCIN	Direct_Rx	ANDA	Current