Details for New Drug Application (NDA): 208767
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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 208767
Tradename: | CLINDAMYCIN PHOSPHATE |
Applicant: | Zydus Lifesciences |
Ingredient: | clindamycin phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208767
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 208767
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | clindamycin phosphate | SOLUTION;TOPICAL | 208767 | ANDA | RPK Pharmaceuticals, Inc. | 53002-8371 | 53002-8371-1 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (53002-8371-1) / 30 mL in 1 BOTTLE, WITH APPLICATOR |
CLINDAMYCIN PHOSPHATE | clindamycin phosphate | SOLUTION;TOPICAL | 208767 | ANDA | RPK Pharmaceuticals, Inc. | 53002-8371 | 53002-8371-2 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (53002-8371-2) / 60 mL in 1 BOTTLE, WITH APPLICATOR |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | EQ 1% BASE | ||||
Approval Date: | Jul 16, 2018 | TE: | AT | RLD: | No |
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