Details for New Drug Application (NDA): 214401
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NDA 214401 describes CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, which is a drug marketed by Abraxis Pharm, Hikma, Abbott Labs, and Baxter Hlthcare, and is included in five NDAs. It is available from one supplier. Additional details are available on the CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% profile page.
The generic ingredient in CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
The generic ingredient in CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 214401
| Tradename: | CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% |
| Applicant: | Hikma |
| Ingredient: | clindamycin phosphate |
| Patents: | 0 |
Pharmacology for NDA: 214401
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 214401
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% | clindamycin phosphate | INJECTABLE;INJECTION | 214401 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9267 | 0143-9267-01 | 1 VIAL in 1 CARTON (0143-9267-01) / 50 mL in 1 VIAL |
| CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% | clindamycin phosphate | INJECTABLE;INJECTION | 214401 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9268 | 0143-9268-01 | 1 VIAL in 1 CARTON (0143-9268-01) / 50 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 6MG BASE/ML | ||||
| Approval Date: | Apr 5, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 12MG BASE/ML | ||||
| Approval Date: | Apr 5, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 18MG BASE/ML | ||||
| Approval Date: | Apr 5, 2023 | TE: | AP | RLD: | No | ||||
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