Paroxetine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Paroxetine Hydrochloride Hemihydrate.
Product ID | 65862-156_6f8ba9ce-9927-4127-ac80-c2256ca8c5da |
NDC | 65862-156 |
Product Type | Human Prescription Drug |
Proprietary Name | Paroxetine |
Generic Name | Paroxetine Hydrochloride |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2007-07-25 |
Marketing Category | ANDA / DRUG FOR FURTHER PROCESSING |
Application Number | ANDA078406 |
Labeler Name | Aurobindo Pharma Limited |
Substance Name | PAROXETINE HYDROCHLORIDE HEMIHYDRATE |
Active Ingredient Strength | 30 mg/1 |
Pharm Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2007-07-25 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA078406 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2007-07-25 |
Marketing Category | ANDA |
Application Number | ANDA078406 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2010-12-21 |
Marketing End Date | 2012-09-24 |
Marketing Category | ANDA |
Application Number | ANDA078406 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2007-07-25 |
Marketing Category | ANDA |
Application Number | ANDA078406 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2007-07-25 |
Marketing Category | ANDA |
Application Number | ANDA078406 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2007-07-25 |
Marketing Category | ANDA |
Application Number | ANDA078406 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2007-07-25 |
Ingredient | Strength |
---|---|
PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 30 mg/1 |
NDC | Brand Name | Generic Name |
---|---|---|
0378-7001 | Paroxetine | paroxetine hydrochloride hemihydrate |
0378-7002 | Paroxetine | paroxetine hydrochloride hemihydrate |
0378-7003 | Paroxetine | paroxetine hydrochloride hemihydrate |
0378-7004 | Paroxetine | paroxetine hydrochloride hemihydrate |
0574-0279 | Paroxetine | paroxetine |
0615-5576 | Paroxetine | Paroxetine |
0615-5577 | Paroxetine | Paroxetine |
0615-5578 | Paroxetine | Paroxetine |
0615-5579 | Paroxetine | Paroxetine |
0615-7985 | Paroxetine | paroxetine hydrochloride hemihydrate |
0615-8173 | Paroxetine | Paroxetine |
0615-8174 | Paroxetine | Paroxetine |
0615-8359 | Paroxetine | Paroxetine |
68071-1594 | Paroxetine | Paroxetine |
68071-1746 | Paroxetine | Paroxetine |
68071-1740 | Paroxetine | Paroxetine |
68071-3278 | Paroxetine | Paroxetine |
68071-4323 | PAROXETINE | PAROXETINE |
68071-4315 | Paroxetine | Paroxetine |
68071-4283 | PAROXETINE | PAROXETINE |
68071-4316 | Paroxetine | Paroxetine |
68084-044 | Paroxetine | Paroxetine |
68084-045 | Paroxetine | Paroxetine |
68084-047 | Paroxetine | Paroxetine |
68084-046 | Paroxetine | Paroxetine |
68180-647 | PAROXETINE | PAROXETINE |
68180-645 | PAROXETINE | PAROXETINE |
68180-646 | PAROXETINE | PAROXETINE |
68382-097 | Paroxetine | Paroxetine |
68382-001 | Paroxetine | Paroxetine |
68382-099 | Paroxetine | Paroxetine |
68382-098 | Paroxetine | Paroxetine |
68788-0797 | Paroxetine | Paroxetine |
68788-7410 | Paroxetine | Paroxetine |
68788-9074 | Paroxetine | Paroxetine |
68788-9118 | Paroxetine | Paroxetine |
68788-6977 | Paroxetine | Paroxetine |
68788-6870 | Paroxetine | Paroxetine |
68788-9694 | PAROXETINE | PAROXETINE |
68788-6985 | Paroxetine | Paroxetine |
68788-9719 | Paroxetine | Paroxetine |
68788-9718 | Paroxetine | Paroxetine |
70518-0003 | Paroxetine | Paroxetine |
70518-0320 | Paroxetine | Paroxetine |
70518-0550 | Paroxetine | Paroxetine |
70518-0958 | Paroxetine | Paroxetine |
70518-1210 | Paroxetine | Paroxetine |
70518-0964 | PAROXETINE | PAROXETINE |
70518-1253 | Paroxetine | Paroxetine |
70518-0739 | Paroxetine | Paroxetine |