Details for New Drug Application (NDA): 212514
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NDA 212514 describes AMPHOTERICIN B, which is a drug marketed by Eugia Pharma, Spil, Abbott, Abraxis Pharm, Teva Parenteral, and Xgen Pharms, and is included in six NDAs. It is available from three suppliers. Additional details are available on the AMPHOTERICIN B profile page.
The generic ingredient in AMPHOTERICIN B is amphotericin b. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.
The generic ingredient in AMPHOTERICIN B is amphotericin b. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.
Summary for 212514
| Tradename: | AMPHOTERICIN B |
| Applicant: | Spil |
| Ingredient: | amphotericin b |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212514
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPHOTERICIN B | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 212514 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-233 | 62756-233-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (62756-233-01) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE |
| AMPHOTERICIN B | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 212514 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-233 | 62756-233-02 | 10 CARTON in 1 CARTON (62756-233-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE, LIPOSOMAL;INJECTION | Strength | 50MG/VIAL | ||||
| Approval Date: | Dec 14, 2021 | TE: | AB | RLD: | No | ||||
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