Details for New Drug Application (NDA): 215713
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The generic ingredient in TRETINOIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 215713
Tradename: | TRETINOIN |
Applicant: | Taro |
Ingredient: | tretinoin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 215713
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRETINOIN | tretinoin | CREAM;TOPICAL | 215713 | ANDA | NORTHSTAR RX LLC | 16714-270 | 16714-270-01 | 1 TUBE in 1 CARTON (16714-270-01) / 20 g in 1 TUBE |
TRETINOIN | tretinoin | CREAM;TOPICAL | 215713 | ANDA | NORTHSTAR RX LLC | 16714-270 | 16714-270-02 | 1 TUBE in 1 CARTON (16714-270-02) / 45 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.025% | ||||
Approval Date: | Jan 5, 2023 | TE: | AB | RLD: | No |
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