Application 063211

Type: ANDA
Sponsor: PERRIGO CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERYTHROMYCIN	ERYTHROMYCIN	GEL;TOPICAL	2%	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
A063211-001	ERYTHROMYCIN	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	RS	1993-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A063211-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	RS	1993-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	RS	1993-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A063211-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063211-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063211-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063211-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063211-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063211-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063211-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063211-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063211-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063211-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063211-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063211-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063211-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063211-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063211-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063211-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063211-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063211-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063211-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063211-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063211-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063211-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063211-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063211-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063211-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063211-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063211-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063211-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063211-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063211-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063211-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063211-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063211-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063211-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063211-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063211-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063211-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063211-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063211-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063211-001	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
Erythromycin	ERYTHROMYCIN	Bryant Ranch Prepack	10ad1391-32fc-40c0-96d0-675f3c91429f	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063211 application number: ANDA063211 ndc (product): 63629-8652
Erythromycin	ERYTHROMYCIN	Bryant Ranch Prepack	b7d11564-c92d-4eed-bdd9-8fc355e7dfc7	2023-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063211 application number: ANDA063211
Erythromycin	ERYTHROMYCIN	Bryant Ranch Prepack	939bccc7-b4a0-4a5c-a6f5-b12627ff8e9b	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063211 application number: ANDA063211 ndc (product): 63629-8653
Erythromycin	ERYTHROMYCIN	Padagis Israel Pharmaceuticals Ltd	dd64459e-c88f-4ca8-b63b-fb96377a3921	2023-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063211 application number: ANDA063211 ndc (product): 45802-966

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-966	Erythromycin	Erythromycin	Perrigo New York Inc	ANDA	Current
45802-966	Erythromycin	Erythromycin	Perrigo New York Inc	ANDA	Current
45802-966	Erythromycin	Erythromycin	Perrigo New York Inc	ANDA	Current
45802-966	Erythromycin	Erythromycin	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
53217-021	Erythromycin	Erythromycin	Aidarex Pharmaceuticals LLC	ANDA	Current
63629-8652	Erythromycin	Erythromycin	Bryant Ranch Prepack	ANDA	Current
63629-8652	Erythromycin	Erythromycin	Bryant Ranch Prepack	ANDA	Current
63629-8652	Erythromycin	Erythromycin	Bryant Ranch Prepack	ANDA	Current
63629-8653	Erythromycin	Erythromycin	Bryant Ranch Prepack	ANDA	Current
63629-8653	Erythromycin	Erythromycin	Bryant Ranch Prepack	ANDA	Current
63629-8653	Erythromycin	Erythromycin	Bryant Ranch Prepack	ANDA	Current