NDC 68083-446

Thiotepa

Thiotepa

Thiotepa is a Intracavitary; Intravenous; Intravesical Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Thiotepa.

Product ID68083-446_283f8e9e-6f72-4e0b-9459-e7d4430ad0ee
NDC68083-446
Product TypeHuman Prescription Drug
Proprietary NameThiotepa
Generic NameThiotepa
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Marketing Start Date2021-03-08
Marketing CategoryANDA /
Application NumberANDA214222
Labeler NameGland Pharma Limited
Substance NameTHIOTEPA
Active Ingredient Strength15 mg/1
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68083-446-01

1 VIAL in 1 CARTON (68083-446-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Marketing Start Date2021-03-08
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0143-9309ThiotepaThiotepa
0143-9565ThiotepaThiotepa
25021-246ThiotepaThiotepa
43598-171ThiotepaThiotepa
43598-650ThiotepaThiotepa
54879-014ThiotepaThiotepa
65219-029ThiotepaThiotepa
68083-446ThiotepaThiotepa
68083-503ThiotepaThiotepa
69539-123ThiotepaThiotepa
69539-124ThiotepaThiotepa
70860-220Thiotepathiotepa
72205-045ThiotepaThiotepa
72205-046ThiotepaThiotepa
53964-001TEPADINATHIOTEPA
53964-002TEPADINATHIOTEPA
70121-1630TEPADINATHIOTEPA
70121-1631TEPADINATHIOTEPA

Trademark Results [Thiotepa]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THIOTEPA
THIOTEPA
73471323 not registered Dead/Abandoned
AMERICAN CYANAMID COMPANY
1984-03-21

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