Details for New Drug Application (NDA): 207402
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NDA 207402 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 207402
| Tradename: | CLINDAMYCIN HYDROCHLORIDE |
| Applicant: | Micro Labs |
| Ingredient: | clindamycin hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207402
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 207402
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 207402 | ANDA | Micro Labs Limited | 42571-250 | 42571-250-01 | 100 CAPSULE in 1 BOTTLE (42571-250-01) |
| CLINDAMYCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 207402 | ANDA | Micro Labs Limited | 42571-250 | 42571-250-67 | 90 BLISTER PACK in 1 CARTON (42571-250-67) / 10 CAPSULE in 1 BLISTER PACK (42571-250-32) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Nov 5, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Nov 5, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 300MG BASE | ||||
| Approval Date: | Nov 5, 2018 | TE: | AB | RLD: | No | ||||
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