NDC 72485-216

Docetaxel

Docetaxel

Docetaxel is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Armas Pharmaceuticals Inc.. The primary component is Docetaxel.

Product ID72485-216_10308491-d534-4e9f-9fcc-8d8a3eda213d
NDC72485-216
Product TypeHuman Prescription Drug
Proprietary NameDocetaxel
Generic NameDocetaxel
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-01-15
Marketing CategoryANDA / ANDA
Application NumberANDA210327
Labeler NameArmas Pharmaceuticals Inc.
Substance NameDOCETAXEL
Active Ingredient Strength160 mg/8mL
Pharm ClassesMicrotubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 72485-216-08

1 VIAL, SINGLE-USE in 1 CARTON (72485-216-08) > 8 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2020-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72485-216-08 [72485021608]

Docetaxel INJECTION
Marketing CategoryANDA
Application NumberANDA210327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-01-15

Drug Details

Active Ingredients

IngredientStrength
DOCETAXEL160 mg/8mL

Pharmacological Class

  • Microtubule Inhibition [PE]
  • Microtubule Inhibitor [EPC]

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

NDCBrand NameGeneric Name
0143-9204DocetaxelDocetaxel
0143-9205DocetaxelDocetaxel
0409-0016DocetaxelDOCETAXEL ANHYDROUS
0409-0201DocetaxelDOCETAXEL ANHYDROUS
0409-0365DocetaxelDOCETAXEL
0409-0366DocetaxelDOCETAXEL
0409-0367DocetaxelDOCETAXEL
0409-0368DocetaxelDOCETAXEL
0409-1732DocetaxelDOCETAXEL ANHYDROUS
0409-2026DocetaxelDOCETAXEL ANHYDROUS
0409-4235DocetaxelDOCETAXEL
70121-1222DocetaxelDocetaxel
70121-1223DocetaxelDocetaxel
70121-1221DocetaxelDocetaxel
0955-1022DocetaxelDocetaxel
0955-1020DocetaxelDocetaxel
0955-1021DocetaxelDocetaxel
16729-267DocetaxelDocetaxel
16729-231DocetaxelDocetaxel
25021-245DocetaxelDocetaxel
39822-2200DocetaxelDocetaxel
39822-2120DocetaxelDocetaxel
39822-2180DocetaxelDocetaxel
43066-001DocetaxelDocetaxel
43066-006DocetaxelDocetaxel
43066-010DocetaxelDocetaxel
43598-610DocetaxelDocetaxel
43598-258DocetaxelDocetaxel
43598-259DocetaxelDocetaxel
43598-611DocetaxelDocetaxel
45963-790DocetaxelDocetaxel
45963-734DocetaxelDocetaxel
45963-765DocetaxelDocetaxel
50742-428DOCETAXELDOCETAXEL
50742-463DOCETAXELDOCETAXEL
50742-431DOCETAXELDOCETAXEL
57884-3043DocetaxelDocetaxel
57884-3021DocetaxelDocetaxel
57884-3042DocetaxelDocetaxel
57884-3041DocetaxelDocetaxel
63739-932DocetaxelDocetaxel
63739-971DocetaxelDocetaxel
66758-950DocetaxelDocetaxel
66758-050DocetaxelDocetaxel
67457-531DocetaxelDocetaxel
67457-533DocetaxelDocetaxel
67457-532DocetaxelDocetaxel
67457-781DocetaxelDocetaxel
0075-8003TAXOTEREDocetaxel
0075-8004TAXOTEREDocetaxel

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