Details for New Drug Application (NDA): 214604
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The generic ingredient in CLINDAMYCIN PHOSPHATE is clindamycin phosphate; tretinoin. There are fifty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.
Summary for 214604
Tradename: | CLINDAMYCIN PHOSPHATE |
Applicant: | Padagis Israel |
Ingredient: | clindamycin phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214604
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 214604
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | clindamycin phosphate | LOTION;TOPICAL | 214604 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-128 | 45802-128-01 | 60 mL in 1 BOTTLE (45802-128-01) |
CLINDAMYCIN PHOSPHATE | clindamycin phosphate | LOTION;TOPICAL | 214604 | ANDA | Bryant Ranch Prepack | 63629-8632 | 63629-8632-1 | 60 mL in 1 BOTTLE (63629-8632-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | EQ 1% BASE | ||||
Approval Date: | Mar 8, 2021 | TE: | AB | RLD: | No |
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