Application 210220

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFDINIR	CEFDINIR	CAPSULE;ORAL	300MG	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
A210220-001	CEFDINIR	CEFDINIR	300MG	CAPSULE / ORAL	AB		2021-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210220-001	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	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`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	A210220-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210220-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210220-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210220-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210220-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210220-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210220-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210220-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210220-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210220-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210220-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210220-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210220-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210220-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210220-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210220-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210220-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210220-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210220-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210220-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210220-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210220-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210220-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210220-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210220-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210220-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210220-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210220-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210220-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210220-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210220-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210220-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210220-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210220-001	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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	Northwind Health Company, LLC	1d0d50ba-8c2b-855c-e063-6394a90a5c7d	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	Proficient Rx LP	63d2f931-6896-47e5-905e-4f812d6cb105	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220 ndc (product): 71205-576
Cefdinir	CEFDINIR	REMEDYREPACK INC.	a8029f7c-6353-46db-8c8c-c86a9485a14f	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	c23af6af-a97b-b98d-e053-2995a90ae780	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220 ndc (product): 68071-2401
Cefdinir	CEFDINIR	Major Pharmaceuticals	a0934baf-4745-4546-a63a-d4a660a188b3	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	Bryant Ranch Prepack	63aa0304-574f-4d37-9fb4-26ffb058fbec	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220 ndc (product): 63629-8968
Cefdinir	CEFDINIR	Bryant Ranch Prepack	d5fd32d8-66de-4a9f-9b83-88b190a90377	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	Ascend Laboratories, LLC	18888955-4db3-4d0d-939f-eaaa5f2e0dc4	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220 ndc (product): 67877-543
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	c5142dca-4fb8-467d-910a-e8228e694c94	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220 ndc (product): 68788-7987
Cefdinir	CEFDINIR	Redpharm Drug, Inc.	f3d228c8-bde9-ffcf-e053-2a95a90aa5c4	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
CEFDINIR	CEFDINIR	DirectRx	d70b9e1f-908f-b570-e053-2995a90af098	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220 ndc (product): 72189-308
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	c974d975-8616-3551-e053-2995a90a65f3	2025-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220 ndc (product): 68071-2503
Cefdinir	CEFDINIR	American Health Packaging	c493e78b-afa3-4f74-8305-75e5f3817df0	2024-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	A-S Medication Solutions	10bf69e7-5f7e-4448-9f22-777f137d9666	2023-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220 ndc (product): 50090-6042
Cefdinir	CEFDINIR	A-S Medication Solutions	a217d454-4ca0-4b29-8a64-eb9393a85269	2023-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220 ndc (product): 50090-6041

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
50090-6041	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-6042	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
63629-8968	Cefdinir	Cefdinir	Bryant Ranch Prepack	ANDA	Current
63629-8969	Cefdinir	Cefdinir	Bryant Ranch Prepack	ANDA	Current
67877-524	Cefdinir	Cefdinir	Ascend Laboratories, LLC	ANDA	Current
67877-543	Cefdinir	Cefdinir	Ascend Laboratories, LLC	ANDA	Current
67877-543	Cefdinir	Cefdinir	Ascend Laboratories, LLC	ANDA	Current
68071-2401	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2401	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2503	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7987	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7987	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-576	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
71205-576	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
72189-308	CEFDINIR	CEFDINIR	DirectRx	ANDA	Current
72189-308	CEFDINIR	CEFDINIR	DirectRx	ANDA	Current