Details for New Drug Application (NDA): 212309
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NDA 212309 describes FOSAPREPITANT DIMEGLUMINE, which is a drug marketed by Accord Hlthcare, Apotex, Arthur Grp, Aspiro, Baxter Hlthcare Corp, Be Pharms, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Geneyork Pharms, Lupin Ltd, MSN, Mylan Labs Ltd, Navinta Llc, Piramal Critical, Qilu Pharm Hainan, Sandoz, and Teva Pharms Usa, and is included in nineteen NDAs. It is available from nineteen suppliers. Additional details are available on the FOSAPREPITANT DIMEGLUMINE profile page.
The generic ingredient in FOSAPREPITANT DIMEGLUMINE is fosaprepitant dimeglumine. There are eleven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.
The generic ingredient in FOSAPREPITANT DIMEGLUMINE is fosaprepitant dimeglumine. There are eleven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.
Summary for 212309
| Tradename: | FOSAPREPITANT DIMEGLUMINE |
| Applicant: | Be Pharms |
| Ingredient: | fosaprepitant dimeglumine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212309
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSAPREPITANT DIMEGLUMINE | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 212309 | ANDA | Cipla USA Inc. | 69097-830 | 69097-830-37 | 1 VIAL, SINGLE-DOSE in 1 CARTON (69097-830-37) / 5 mL in 1 VIAL, SINGLE-DOSE |
| FOSAPREPITANT DIMEGLUMINE | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 212309 | ANDA | BE Pharmaceuticals Inc. | 71839-104 | 71839-104-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71839-104-01) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 150MG BASE/VIAL | ||||
| Approval Date: | Sep 5, 2019 | TE: | AP | RLD: | No | ||||
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