Details for New Drug Application (NDA): 213385
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The generic ingredient in PREDNISONE is prednisone. There are sixteen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the prednisone profile page.
Summary for 213385
Tradename: | PREDNISONE |
Applicant: | Amneal |
Ingredient: | prednisone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213385
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 213385
Suppliers and Packaging for NDA: 213385
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREDNISONE | prednisone | TABLET;ORAL | 213385 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8439 | 0615-8439-05 | 15 TABLET in 1 BLISTER PACK (0615-8439-05) |
PREDNISONE | prednisone | TABLET;ORAL | 213385 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8439 | 0615-8439-39 | 30 TABLET in 1 BLISTER PACK (0615-8439-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Jun 16, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jun 16, 2020 | TE: | AB | RLD: | No |
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