Details for New Drug Application (NDA): 210221
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The generic ingredient in CEPHALEXIN is cephalexin. There are twenty-nine drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
Summary for 210221
Tradename: | CEPHALEXIN |
Applicant: | Alkem Labs Ltd |
Ingredient: | cephalexin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210221
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEPHALEXIN | cephalexin | FOR SUSPENSION;ORAL | 210221 | ANDA | A-S Medication Solutions | 50090-4795 | 50090-4795-0 | 200 mL in 1 BOTTLE (50090-4795-0) |
CEPHALEXIN | cephalexin | FOR SUSPENSION;ORAL | 210221 | ANDA | A-S Medication Solutions | 50090-5196 | 50090-5196-0 | 100 mL in 1 BOTTLE (50090-5196-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 125MG BASE/5ML | ||||
Approval Date: | Mar 26, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 250MG BASE/5ML | ||||
Approval Date: | Mar 26, 2019 | TE: | AB | RLD: | No |
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