This page includes the latest FDA filings for Alkem Laboratories L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
INDIA | NATIONAL STOCK EXCHANGE OF INDIA | ALKEM | DUNS 650066939 |
Device Company | Device | Date |
---|---|---|
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2025-01-12 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-12-28 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-12-25 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-12-25 |
American Health Packaging, Alkem Laboratories Limited | Prescription Medication | 2024-12-20 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-12-07 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-11-30 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-11-15 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-10-22 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-10-12 |
Ascend Laboratories, LLC, Shilpa Medicare Limited, Alkem Laboratories Limited | Prescription Medication | 2024-10-01 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-09-21 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-09-18 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-09-15 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-09-06 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-08-31 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-08-30 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-08-23 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-08-22 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-08-22 |
NCS HealthCare of KY, LLC dba Vangard Labs | Prescription Medication | 2024-08-20 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-08-10 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-07-30 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-07-17 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-07-16 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-07-16 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-07-10 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-07-04 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-07-04 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-06-29 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-06-29 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-06-22 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-06-12 |
NCS HealthCare of KY, LLC dba Vangard Labs | Prescription Medication | 2024-06-12 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-05-21 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-05-10 |
Golden State Medical Supply, Inc., Alkem Laboratories Limited | Prescription Medication | 2024-05-04 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-04-20 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-04-20 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-03-31 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-03-29 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-02-29 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-02-16 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-02-09 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-01-26 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-01-23 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2024-01-23 |
McKesson Corporation dba Sky Packaging, Alkem Laboratories Limited | Prescription Medication | 2023-12-29 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-12-29 |
NorthStar RxLLC, Alkem Laboratories Limited | Prescription Medication | 2023-12-27 |
NorthStar RxLLC, Alkem Laboratories Limited | Prescription Medication | 2023-12-27 |
McKesson Corporation dba Sky Packaging, Alkem Laboratories Limited | Prescription Medication | 2023-12-27 |
Major Pharmaceuticals, Alkem Laboratories Limited | Prescription Medication | 2023-12-23 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-12-19 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-12-14 |
American Health Packaging, Alkem Laboratories Limited | Prescription Medication | 2023-12-13 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-12-13 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-12-10 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-12-06 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-12-05 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-12-02 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-11-23 |
Chartwell RX, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-11-11 |
Major Pharmaceuticals, Alkem Laboratories Limited | Prescription Medication | 2023-11-10 |
Chartwell RX, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-11-09 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-11-01 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-09-30 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-09-21 |
Chartwell RX, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-09-15 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-09-02 |
NCS HealthCare of KY, LLC dba Vangard Labs | Prescription Medication | 2023-09-01 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-08-31 |
BluePoint Laboratories, Alkem Laboratories Limited | Prescription Medication | 2023-08-30 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-08-30 |
NCS HealthCare of KY, LLC dba Vangard Labs | Prescription Medication | 2023-08-05 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-08-01 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-08-01 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-07-29 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-07-29 |
Ascend Laboratories, LLC, Shilpa Medicare Limited, Alkem Laboratories Limited | Prescription Medication | 2023-07-29 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-07-22 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-07-22 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-07-21 |
Amici Pharmaceuticals, LLC., Alkem Laboratories Limited | Prescription Medication | 2023-07-14 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-07-14 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-07-12 |
Amici Pharmaceuticals, LLC., Alkem Laboratories Limited | Prescription Medication | 2023-06-16 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-06-09 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-06-03 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-05-20 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-05-16 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-05-11 |
BluePoint Laboratories, Alkem Laboratories Limited | Prescription Medication | 2023-05-10 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-04-29 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-04-29 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-04-29 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-04-27 |
NCS HealthCare of KY, LLC dba Vangard Labs, Alkem Laboratories Limited | Prescription Medication | 2023-04-27 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-04-19 |
Ascend Laboratories, LLC, Alkem Laboratories Limited | Prescription Medication | 2023-03-29 |
Alkem Laboratories Limited | 2021-01-07 | |
Alkem Laboratories Limited | 2018-01-16 |
NCAGE Code | 2542Y | ALKEM LABORATORIES LIMITED |
NCAGE Code | SDUZ3 | ALKEM LABORATORIES LIMITED |
CAGE Code | 2542Y | ALKEM LABORATORIES LIMITED |
CAGE Code | SDUZ3 | ALKEM LABORATORIES LIMITED |
Import ID | Shipment | Cargo Description | Quantity |
---|---|---|---|
2020092940696 | Nhava Sheva,India -> Norfolk, Virginia | 1068 SHIPPER PACKED IN 38 PACKAGES PHARMACEUT ICAL PRODUCTS GABAPENTIN 300MG CAPSULES1000S NDC NO: 67877-223-10 GABAPENTIN 400MG CAPS 50 0S NDC NO: 67877-224-05 AMLODIPINE BESYLATE T AB 5MG1000S NDC NO: 67877-198-10 EZETIMIBE&SI MVASTATIN TABS1040MG90S NDC NO: 67877-509-90 QUETIAPINE TABLETS USP 300MG 1000S NDC NO: 67 | 1068 BOX |
2020092940697 | Nhava Sheva,India -> Norfolk, Virginia | 1018 SHIPPER PACKED IN 40 PACKAGES PHARMACEUT ICAL PRODUCTS GABAPENTIN 400MG CAPS 500S NDC NO: 6787722405 GABAPENTIN 300MG CAPSULES 500S NDC NO: 6787722305 GABAPENTIN 300MG CAPSULES 1000S NDC NO: 6787722310 EZETIMIBE TABLETS US P 10MG 90S NDC NO: 6787749090 CHLORTHALIDONE TABLETS USP 50MG 100S NDC NO: 6787769701 DATA | 1018 BOX |
2020092934828 | Nhava Sheva,India -> Norfolk, Virginia | 40 PALLETS ( 827 PACKAGES) (1X40 | 827 PKG |
2020092934852 | Nhava Sheva,India -> Norfolk, Virginia | 40 PALLETS ( 868 PACKAGES) (1X40 | 868 PKG |
2020092934713 | Nhava Sheva,India -> Norfolk, Virginia | 42 PALLETS ( 942 PACKAGES) (1X40 | 942 PKG |
2020092940704 | Nhava Sheva,India -> Norfolk, Virginia | 616 SHIPPER PACKED IN 39 PACKAGES PHARMACEUTI CAL PRODUCTS FINASTERIDE TABS USP 5MG 90S NDC NO: 6787728890 AMLODIPINE BESYLATE TAB 5MG10 00S NDC NO: 6787719810 EZETIMIBE TABLETS USP 10MG 500S NDC NO: 6787749005 GABAPENTIN 300MG CAPSULES 500S NDC NO: 6787722305 GABAPENTIN CAPSULES USP 400MG100S NDC NO: 6787722401 DAT | 616 BOX |
2020092940705 | Nhava Sheva,India -> Norfolk, Virginia | 1181 SHIPPER PACKED IN 40 PACKAGES PHARMACEUT ICAL PRODUCTS GABAPENTIN TABLETS USP 800MG 50 0S NDC NO: 6787742905 AMLODIPINE TAB 5MG90S N O COTTON &DESI NDC NO: 6787719890 DALFAMPRIDI NE ER TABLETS 10MG 60S NDC NO: 6787744460 DAT A LOGGER NO. R0124639, BATCH NO. 20121612, SH IPPER NO. 164 DATA LOGGER NO. R0124672, BATCH | 1181 BOX |
2020092516864 | Nhava Sheva,India -> Norfolk, Virginia | 581 PACKAGES | 581 PKG |