Details for New Drug Application (NDA): 201835
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The generic ingredient in METHYLPREDNISOLONE ACETATE is methylprednisolone acetate. There are forty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
Summary for 201835
Tradename: | METHYLPREDNISOLONE ACETATE |
Applicant: | Sagent Pharms Inc |
Ingredient: | methylprednisolone acetate |
Patents: | 0 |
Pharmacology for NDA: 201835
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 201835
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 201835 | ANDA | Sagent Pharmaceuticals | 25021-820 | 25021-820-05 | 1 VIAL in 1 CARTON (25021-820-05) / 5 mL in 1 VIAL |
METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 201835 | ANDA | Sagent Pharmaceuticals | 25021-820 | 25021-820-10 | 1 VIAL in 1 CARTON (25021-820-10) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
Approval Date: | Jun 27, 2018 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/ML | ||||
Approval Date: | Jun 27, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/ML | ||||
Approval Date: | Jun 27, 2018 | TE: | AB | RLD: | No |
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