NDC 0378-8086

Tretionin

Tretionin

Tretionin is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Tretinoin.

Product ID0378-8086_22767e97-7665-4f39-9cbf-af0025526a15
NDC0378-8086
Product TypeHuman Prescription Drug
Proprietary NameTretionin
Generic NameTretionin
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2019-07-12
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA017579
Labeler NameMylan Pharmaceuticals Inc.
Substance NameTRETINOIN
Active Ingredient Strength0 mg/g
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-8086-15

1 TUBE in 1 CARTON (0378-8086-15) > 15 g in 1 TUBE
Marketing Start Date2019-07-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8086-45 [00378808645]

Tretionin GEL
Marketing CategoryNDA authorized generic
Application NumberNDA017579
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-07-25

NDC 0378-8086-15 [00378808615]

Tretionin GEL
Marketing CategoryNDA authorized generic
Application NumberNDA017579
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-07-12

Drug Details

Pharmacological Class

  • Retinoid [EPC]
  • Retinoids [CS]

NDC Crossover Matching brand name "Tretionin" or generic name "Tretionin"

NDCBrand NameGeneric Name
0378-8082TretioninTretionin
0378-8083TretioninTretionin
0378-8084TretioninTretionin
0378-8085TretioninTretionin
0378-8086TretioninTretionin

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.