Details for New Drug Application (NDA): 065442
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NDA 065442 describes CLINDAMYCIN HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Micro Labs, Mylan Pharms Inc, Sun Pharm Inds Ltd, Teva, Watson Labs, and Zydus Pharms Usa, and is included in twelve NDAs. It is available from thirty-two suppliers. Additional details are available on the CLINDAMYCIN HYDROCHLORIDE profile page.
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.
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 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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