Details for New Drug Application (NDA): 211644
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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 211644
Tradename: | TRETINOIN |
Applicant: | Taro |
Ingredient: | tretinoin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211644
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRETINOIN | tretinoin | CREAM;TOPICAL | 211644 | ANDA | NORTHSTAR RX LLC | 16714-249 | 16714-249-01 | 1 TUBE in 1 CARTON (16714-249-01) / 20 g in 1 TUBE |
TRETINOIN | tretinoin | CREAM;TOPICAL | 211644 | ANDA | NORTHSTAR RX LLC | 16714-249 | 16714-249-02 | 1 TUBE in 1 CARTON (16714-249-02) / 45 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Jan 25, 2019 | TE: | AB1 | RLD: | No |
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