Details for New Drug Application (NDA): 201692
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NDA 201692 describes CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare Corp, Rising, and Sandoz Inc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER profile page.
The generic ingredient in CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
The generic ingredient in CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 201692
| Tradename: | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER |
| Applicant: | Sandoz Inc |
| Ingredient: | clindamycin phosphate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201692
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 201692
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | clindamycin phosphate | INJECTABLE;INJECTION | 201692 | ANDA | Sandoz Inc | 0781-3288 | 0781-3288-09 | 24 BAG in 1 CARTON (0781-3288-09) / 50 mL in 1 BAG (0781-3288-91) |
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | clindamycin phosphate | INJECTABLE;INJECTION | 201692 | ANDA | Sandoz Inc | 0781-3289 | 0781-3289-09 | 24 BAG in 1 CARTON (0781-3289-09) / 50 mL in 1 BAG (0781-3289-91) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 6MG BASE/ML | ||||
| Approval Date: | May 31, 2012 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 12MG BASE/ML | ||||
| Approval Date: | May 31, 2012 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 18MG BASE/ML | ||||
| Approval Date: | May 31, 2012 | TE: | AP | RLD: | No | ||||
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