Bosentan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Bosentan.
Product ID | 47335-039_a2829acd-794e-46c7-a603-37fdcf54a38a |
NDC | 47335-039 |
Product Type | Human Prescription Drug |
Proprietary Name | Bosentan |
Generic Name | Bosentan |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2019-04-26 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA209324 |
Labeler Name | Sun Pharmaceutical Industries, Inc. |
Substance Name | BOSENTAN |
Active Ingredient Strength | 125 mg/1 |
Pharm Classes | Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2019-04-26 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA209324 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-04-26 |
Marketing Category | ANDA |
Application Number | ANDA209324 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-04-26 |
Marketing Category | ANDA |
Application Number | ANDA209324 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-04-26 |
Ingredient | Strength |
---|---|
BOSENTAN | 125 mg/1 |
NDC | Brand Name | Generic Name |
---|---|---|
0054-0520 | Bosentan | Bosentan |
0054-0521 | Bosentan | Bosentan |
0591-2511 | bosentan | bosentan |
0591-2512 | bosentan | bosentan |
10148-125 | bosentan | bosentan |
10148-625 | bosentan | bosentan |
46708-383 | Bosentan | Bosentan |
46708-384 | Bosentan | Bosentan |
47335-038 | Bosentan | Bosentan |
47335-039 | Bosentan | Bosentan |
47781-270 | Bosentan | Bosentan |
47781-271 | Bosentan | Bosentan |
49884-058 | Bosentan | Bosentan |
49884-059 | Bosentan | Bosentan |
62332-383 | Bosentan | Bosentan |
62332-384 | Bosentan | Bosentan |
65162-873 | Bosentan | Bosentan |
65162-874 | Bosentan | Bosentan |
69097-377 | BOSENTAN | BOSENTAN |
69097-378 | BOSENTAN | BOSENTAN |
68382-446 | Bosentan | Bosentan |
68382-447 | Bosentan | Bosentan |
70771-1017 | Bosentan | Bosentan |
70771-1018 | Bosentan | Bosentan |
68180-387 | Bosentan | Bosentan |
68180-386 | Bosentan | Bosentan |
66215-101 | Tracleer | bosentan |