Details for New Drug Application (NDA): 216502
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NDA 216502 describes METHYLPREDNISOLONE ACETATE, which is a drug marketed by Amneal, Endo Operations, Epic Pharma Llc, Eugia Pharma, Hong Kong, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Watson Labs, and Wilshire Pharms Inc, and is included in seventeen NDAs. It is available from ten 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
Summary for 216502
| Tradename: | METHYLPREDNISOLONE ACETATE |
| Applicant: | Amneal |
| Ingredient: | methylprednisolone acetate |
| Patents: | 0 |
Pharmacology for NDA: 216502
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 216502
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 216502 | ANDA | Amneal Pharmaceuticals LLC | 70121-1609 | 70121-1609-1 | 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1609-1) / 10 mL in 1 VIAL, MULTI-DOSE |
| METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 216502 | ANDA | Amneal Pharmaceuticals LLC | 70121-1609 | 70121-1609-5 | 25 VIAL, MULTI-DOSE in 1 CARTON (70121-1609-5) / 10 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/ML | ||||
| Approval Date: | Nov 3, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/ML | ||||
| Approval Date: | Nov 3, 2023 | TE: | AB | RLD: | No | ||||
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