Details for New Drug Application (NDA): 065442
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The generic ingredient in CLINDAMYCIN HYDROCHLORIDE is clindamycin hydrochloride. There are fifty-five drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.
Summary for 065442
Tradename: | CLINDAMYCIN HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | clindamycin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065442
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 065442
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 065442 | ANDA | Major Pharmaceuticals | 0904-7194 | 0904-7194-61 | 100 BLISTER PACK in 1 CARTON (0904-7194-61) / 1 CAPSULE in 1 BLISTER PACK |
CLINDAMYCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 065442 | ANDA | A-S Medication Solutions | 50090-3907 | 50090-3907-0 | 30 CAPSULE in 1 BOTTLE (50090-3907-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Aug 26, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 300MG BASE | ||||
Approval Date: | Aug 26, 2009 | TE: | AB | RLD: | No |
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