Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040377
Company: PRINSTON INC
Company: PRINSTON INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET;ORAL | Prescription | AA | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/04/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40377ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/31/2017 | SUPPL-14 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/06/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/06/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
PHENTERMINE HYDROCHLORIDE
TABLET;ORAL; 37.5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADIPEX-P | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET;ORAL | Prescription | Yes | AA | 085128 | TEVA |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET;ORAL | Prescription | No | AA | 203068 | AUROLIFE PHARMA LLC |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET;ORAL | Prescription | No | AA | 200272 | ELITE LABS |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET;ORAL | Prescription | No | AA | 040190 | ELITE LABS INC |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET;ORAL | Prescription | No | AA | 040876 | KVK TECH |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET;ORAL | Prescription | No | AA | 206342 | MERRO PHARM USA |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET;ORAL | Prescription | No | AA | 205008 | NUVO PHARM |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET;ORAL | Prescription | No | AA | 040377 | PRINSTON INC |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET;ORAL | Prescription | No | AA | 040526 | SUN PHARM INDUSTRIES |