Application 211792

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZITHROMYCIN	AZITHROMYCIN	TABLET;ORAL	EQ 500MG BASE	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
A211792-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB		2020-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211792-001	AB

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.

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	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211792-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2020-01-28	`a50c72e98297…`

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	A211792-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211792-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211792-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211792-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211792-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211792-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211792-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211792-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211792-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211792-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211792-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211792-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211792-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211792-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211792-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211792-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211792-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211792-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211792-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211792-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211792-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211792-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211792-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211792-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211792-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211792-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211792-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211792-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211792-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211792-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211792-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211792-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211792-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211792-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211792-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211792-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211792-001	AB	1	`a50c72e98297…`

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
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	614cc2a4-3fc7-455d-9e8a-212c496f0fbf	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211792 application number: ANDA211792 ndc (product): 70518-3254
Azithromycin	AZITHROMYCIN	Alembic Pharmaceuticals Limited	d5c95c30-564f-4b67-ac6d-9179cdfaa5a8	2023-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211792 application number: ANDA211792 ndc (product): 46708-058
Azithromycin	AZITHROMYCIN	Alembic Pharmaceuticals Inc.	45410338-6bff-476b-b8e1-6c6238205a99	2022-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211792 application number: ANDA211792 ndc (product): 62332-252

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-058	Azithromycin	Azithromycin	Alembic Pharmaceuticals Limited	ANDA	Current
62332-252	Azithromycin	Azithromycin	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-252	Azithromycin	Azithromycin	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-252	Azithromycin	Azithromycin	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-252	Azithromycin	Azithromycin	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-252	Azithromycin	Azithromycin	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-252	Azithromycin	Azithromycin	Alembic Pharmaceuticals Inc.	ANDA	Current
70518-3254	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-3254	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-3254	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current