Details for New Drug Application (NDA): 201835
✉ Email this page to a colleague
NDA 201835 describes METHYLPREDNISOLONE ACETATE, which is a drug marketed by Amneal, Epic Pharma Llc, Eugia Pharma, Hikma, Hong Kong, Ph Health, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Watson Labs, and Wilshire Pharms Inc, and is included in eighteen NDAs. It is available from eight suppliers. Additional details are available on the METHYLPREDNISOLONE ACETATE profile page.
The generic ingredient in METHYLPREDNISOLONE ACETATE is methylprednisolone acetate. There are forty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
The generic ingredient in METHYLPREDNISOLONE ACETATE is methylprednisolone acetate. There are forty drug master file entries for this compound. Ten 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 | ||||
Complete Access Available with Subscription
