Application 210534

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFDINIR	CEFDINIR	FOR SUSPENSION;ORAL	125MG/5ML	No	No
002	CEFDINIR	CEFDINIR	FOR SUSPENSION;ORAL	250MG/5ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210534-001	CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2021-02-19
A210534-002	CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2021-02-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210534-001	AB
A210534-002	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.

Product history page 1 of 2 · 68 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	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A210534-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210534-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210534-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210534-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210534-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210534-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210534-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210534-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210534-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210534-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210534-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210534-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210534-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210534-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210534-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210534-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210534-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210534-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210534-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210534-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210534-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210534-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210534-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210534-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210534-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210534-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210534-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210534-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210534-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210534-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210534-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210534-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210534-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210534-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210534-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210534-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210534-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210534-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210534-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210534-002	AB	1	`87673890dc5c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	2e384d98-642e-4841-9f62-fcea4c242f4e	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210534 application number: ANDA210534 ndc (product): 68788-8115
cefdinir	CEFDINIR	A-S Medication Solutions	2bd2101c-511d-45a9-b1d8-a45ed40c5b80	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210534 application number: ANDA210534
CEFDINIR	CEFDINIR	DIRECT RX	982d0f53-20bc-1cb4-e053-2995a90ad33c	2025-01-22	Warnings	Exact identifier application applno (ANDA): 210534 application number: ANDA210534 ndc (product): 72189-259
cefdinir	CEFDINIR	A-S Medication Solutions	7bbcc4ac-c964-4c6b-88c0-11c0ba9933db	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210534 application number: ANDA210534 ndc (product): 50090-5811
cefdinir	CEFDINIR	Ascend Laboratories, LLC	efb5a975-75ec-46e1-ba84-f68d0b9bf36f	2022-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210534 application number: ANDA210534 ndc (product): 67877-548 ndc (product): 67877-547

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5811	cefdinir	cefdinir	A-S Medication Solutions	ANDA	Current
67877-547	cefdinir	cefdinir	Ascend Laboratories, LLC	ANDA	Current
67877-547	cefdinir	cefdinir	Ascend Laboratories, LLC	ANDA	Current
67877-547	cefdinir	cefdinir	Ascend Laboratories, LLC	ANDA	Current
67877-548	cefdinir	cefdinir	Ascend Laboratories, LLC	ANDA	Current
67877-548	cefdinir	cefdinir	Ascend Laboratories, LLC	ANDA	Current
67877-548	cefdinir	cefdinir	Ascend Laboratories, LLC	ANDA	Current
68071-2493	cefdinir	cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2493	cefdinir	cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2564	cefdinir	cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2683	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8062	cefdinir	cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8062	cefdinir	cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8115	cefdinir	cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8115	cefdinir	cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
72189-259	CEFDINIR	CEFDINIR	DIRECT RX	ANDA	Current
72189-259	CEFDINIR	CEFDINIR	DIRECT RX	ANDA	Current