Details for New Drug Application (NDA): 065243
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NDA 065243 describes CLINDAMYCIN HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Micro Labs, Norvium Bioscience, Sun Pharm Inds Ltd, Teva, Watson Labs, and Zydus Pharms Usa, and is included in twelve NDAs. It is available from thirty-five 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.
Summary for 065243
| Tradename: | CLINDAMYCIN HYDROCHLORIDE |
| Applicant: | Chartwell Molecular |
| Ingredient: | clindamycin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 065243
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 065243
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 065243 | ANDA | Chartwell RX, LLC | 62135-764 | 62135-764-01 | 100 CAPSULE in 1 BOTTLE (62135-764-01) |
| CLINDAMYCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 065243 | ANDA | Chartwell RX, LLC | 62135-765 | 62135-765-01 | 100 CAPSULE in 1 BOTTLE (62135-765-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 300MG BASE | ||||
| Approval Date: | Aug 12, 2005 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Aug 12, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Aug 12, 2005 | TE: | RLD: | No | |||||
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