Decitabine is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Usa Llc.. The primary component is Decitabine.
Product ID | 64679-067_0203d7b9-3d86-4a8c-b7e2-11d31d803c71 |
NDC | 64679-067 |
Product Type | Human Prescription Drug |
Proprietary Name | Decitabine |
Generic Name | Decitabine |
Dosage Form | Injection, Powder, Lyophilized, For Solution |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2020-12-14 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA209056 |
Labeler Name | Wockhardt USA LLC. |
Substance Name | DECITABINE |
Active Ingredient Strength | 50 mg/20mL |
Pharm Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2020-12-14 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA209056 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-04-09 |
Marketing Category | ANDA |
Application Number | ANDA209056 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-04-09 |
Ingredient | Strength |
---|---|
DECITABINE | 50 mg/20mL |
SPL SET ID: | c3218c35-c9fb-4bb9-9055-75a6585dfd2e |
Manufacturer | |
UNII |
NDC | Brand Name | Generic Name |
---|---|---|
0143-9385 | decitabine | decitabine |
0781-3139 | Decitabine | Decitabine |
0781-3296 | Decitabine | Decitabine |
16714-749 | Decitabine | Decitabine |
16714-928 | Decitabine | Decitabine |
16729-224 | Decitabine | decitabine |
25021-231 | decitabine | decitabine |
42737-110 | Decitabine | Decitabine |
43598-348 | Decitabine | Decitabine |
43598-427 | Decitabine | Decitabine |
47335-361 | decitabine | decitabine |
50742-430 | DECITABINE | decitabine |
55111-556 | Decitabine | Decitabine |
55150-376 | Decitabine | Decitabine |
68001-347 | Decitabine | Decitabine |
69097-285 | Decitabine | Decitabine |
67457-316 | Decitabine | Decitabine |
64679-067 | Decitabine | Decitabine |
68001-422 | Decitabine | Decitabine |
69539-115 | Decitabine | Decitabine |
63323-825 | Decitabine | Decitabine |
68180-738 | decitabine | decitabine |
70121-1644 | Decitabine | Decitabine |
72205-031 | Decitabine | Decitabine |
72205-036 | Decitabine | Decitabine |
75834-190 | DECITABINE | DECITABINE |
72603-107 | Decitabine | Decitabine |
59148-046 | Dacogen | decitabine |