Details for New Drug Application (NDA): 212845
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The generic ingredient in CLINDAMYCIN PHOSPHATE AND TRETINOIN is clindamycin phosphate; tretinoin. There are fifty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.
Summary for 212845
| Tradename: | CLINDAMYCIN PHOSPHATE AND TRETINOIN |
| Applicant: | Solaris Pharma Corp |
| Ingredient: | clindamycin phosphate; tretinoin |
| Patents: | 0 |
Pharmacology for NDA: 212845
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 212845
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE AND TRETINOIN | clindamycin phosphate; tretinoin | GEL;TOPICAL | 212845 | ANDA | Solaris Pharma Corporation | 73473-306 | 73473-306-30 | 1 TUBE in 1 CARTON (73473-306-30) / 30 g in 1 TUBE |
| CLINDAMYCIN PHOSPHATE AND TRETINOIN | clindamycin phosphate; tretinoin | GEL;TOPICAL | 212845 | ANDA | Solaris Pharma Corporation | 73473-306 | 73473-306-60 | 1 TUBE in 1 CARTON (73473-306-60) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 1.2%;0.025% | ||||
| Approval Date: | Feb 10, 2022 | TE: | AB2 | RLD: | No | ||||
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