Details for New Drug Application (NDA): 080292
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The generic ingredient in PREDNISONE is prednisone. There are sixteen drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the prednisone profile page.
Summary for 080292
Tradename: | PREDNISONE |
Applicant: | Mylan |
Ingredient: | prednisone |
Patents: | 0 |
Pharmacology for NDA: 080292
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 080292
Suppliers and Packaging for NDA: 080292
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREDNISONE | prednisone | TABLET;ORAL | 080292 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0640 | 0378-0640-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0640-01) |
PREDNISONE | prednisone | TABLET;ORAL | 080292 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0640 | 0378-0640-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0640-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No |
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