Details for New Drug Application (NDA): 065217
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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-four suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.
Summary for 065217
Tradename: | CLINDAMYCIN HYDROCHLORIDE |
Applicant: | Zydus Pharms Usa |
Ingredient: | clindamycin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065217
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 065217
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 065217 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-234 | 68382-234-01 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (68382-234-01) |
CLINDAMYCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 065217 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-234 | 68382-234-05 | 500 CAPSULE, GELATIN COATED in 1 BOTTLE (68382-234-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Jan 31, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Jan 31, 2005 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 300MG BASE | ||||
Approval Date: | Jan 31, 2005 | TE: | AB | RLD: | No |
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