Application 210221

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEPHALEXINCEPHALEXINFOR SUSPENSION;ORALEQ 125MG BASE/5MLNoNo
002CEPHALEXINCEPHALEXINFOR SUSPENSION;ORALEQ 250MG BASE/5MLNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210221-001CEPHALEXINCEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26
A210221-002CEPHALEXINCEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210221-001AB
A210221-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210221-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210221-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210221-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210221-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210221-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210221-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210221-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210221-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210221-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210221-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210221-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210221-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210221-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210221-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210221-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210221-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210221-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210221-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210221-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210221-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210221-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210221-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210221-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210221-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210221-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210221-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210221-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210221-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210221-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210221-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210221-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210221-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210221-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210221-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210221-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210221-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210221-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210221-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210221-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210221-002AB1bb7c543d1eb4…

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINBryant Ranch Prepack06c2fb2e-0539-4f16-bac4-e15a575ca8022026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 63629-9206
CephalexinCEPHALEXINPreferred Pharmaceuticlas Inc.fbf5fcdf-40fc-40e5-b784-308032fff0e52026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 68788-7796
CephalexinCEPHALEXINPreferred Pharmaceuticals, Inc.6c7bfa58-2d38-4607-8c33-485ba4931c682026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 68788-7529
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.ee278959-d321-d356-e053-2995a90a32c22026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 68071-2889
CephalexinCEPHALEXINBryant Ranch Prepackc7028200-b141-496b-89e9-491558d4c8792025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepack5f867aa3-ea64-4a14-a63b-979b8ff8d80c2025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINREMEDYREPACK INC.9fc5cfb0-7ba0-4669-b79c-270b6a9ff5732025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepack8d7f247a-3b42-4823-96fb-5f5c1bd94d492025-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 63629-8857
CephalexinCEPHALEXINBryant Ranch Prepack1bfa8744-24ee-4c70-845c-c532b80844332025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepacka8f14231-5d43-46f7-ba1f-d6de8162d5e72024-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 63629-9205
CephalexinCEPHALEXINBryant Ranch Prepacke186afb5-7531-45ea-b785-c230483a77472024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 63629-9207
CephalexinCEPHALEXINBryant Ranch Prepackf1439d25-3d3d-4fe5-b6e7-d76e628929692024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINA-S Medication Solutions28fec572-e3b9-448c-8626-5c0920f38eeb2024-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 50090-4795
CephalexinCEPHALEXINBryant Ranch Prepackdf6bb893-e3d7-4c8f-8cec-35b4d2fa33b32024-07-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 63629-8858
CephalexinCEPHALEXINBryant Ranch Prepackf4ced8c7-a276-4a44-a60c-f8d1689a2bdf2024-07-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 63629-9204
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.ada33464-b416-9ac6-e053-2a95a90af7872024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 68071-2246
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.90a76d24-e5a9-9000-e053-2a95a90ae8af2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 68071-5038
CephalexinCEPHALEXINBryant Ranch Prepack92be9844-0775-4808-bdeb-dccb09647d912024-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINA-S Medication Solutions0edeb103-5e94-4f42-828f-c7336486c7842024-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 50090-5196
CephalexinCEPHALEXINAscend Laboratories, LLCbb28751c-bd1b-4e7f-8271-a14c1b4314e32022-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 67877-544
ndc (product): 67877-545

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4795CephalexinCephalexinA-S Medication SolutionsANDACurrent
50090-5196CephalexinCephalexinA-S Medication SolutionsANDACurrent
55700-841CephalexinCephalexinQuality Care Products, LLCANDACurrent
55700-841CephalexinCephalexinQuality Care Products, LLCANDACurrent
63629-8857CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-8857CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-8857CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-8858CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-8858CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-8858CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9204CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9204CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9204CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9205CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9205CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9205CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9206CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9206CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9206CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9207CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9207CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9207CephalexinCephalexinBryant Ranch PrepackANDACurrent
67877-544CephalexinCephalexinAscend Laboratories, LLCANDACurrent
67877-544CephalexinCephalexinAscend Laboratories, LLCANDACurrent
67877-545CephalexinCephalexinAscend Laboratories, LLCANDACurrent
67877-545CephalexinCephalexinAscend Laboratories, LLCANDACurrent
68071-2246CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2246CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2889CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5038CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5038CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5038CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7529CephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7529CephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7529CephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7796CephalexinCephalexinPreferred Pharmaceuticlas Inc.ANDACurrent
68788-7796CephalexinCephalexinPreferred Pharmaceuticlas Inc.ANDACurrent
68788-7796CephalexinCephalexinPreferred Pharmaceuticlas Inc.ANDACurrent