Details for New Drug Application (NDA): 065061
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NDA 065061 describes CLINDAMYCIN HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Micro Labs, Pharmobedient, Sun Pharm Inds Ltd, Teva, Watson Labs, and Zydus Pharms Usa, and is included in twelve NDAs. It is available from thirty-three 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-five 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-five suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.
Summary for 065061
| Tradename: | CLINDAMYCIN HYDROCHLORIDE |
| Applicant: | Sun Pharm Inds Ltd |
| Ingredient: | clindamycin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 065061
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 065061
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 065061 | ANDA | Major Pharmaceuticals | 0904-5959 | 0904-5959-61 | 100 BLISTER PACK in 1 CARTON (0904-5959-61) / 1 CAPSULE in 1 BLISTER PACK |
| CLINDAMYCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 065061 | ANDA | A-S Medication Solutions | 50090-0967 | 50090-0967-0 | 30 CAPSULE in 1 BOTTLE (50090-0967-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Feb 2, 2001 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 300MG BASE | ||||
| Approval Date: | Feb 2, 2001 | TE: | AB | RLD: | No | ||||
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