Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202248
Company: ELITE LABS
Company: ELITE LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | AA | No | No |
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
09/28/2012 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/31/2017 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
12/05/2012 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
PHENTERMINE HYDROCHLORIDE
CAPSULE;ORAL; 15MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | No | AA | 204318 | AUROLIFE PHARMA LLC |
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | No | AA | 202248 | ELITE LABS |
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | No | AA | 040886 | KVK TECH |
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | No | AA | 205019 | NUVO PHARM |
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | Yes | AA | 087190 | SANDOZ |
CAPSULE;ORAL; 30MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AA | 204318 | AUROLIFE PHARMA LLC |
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AA | 202248 | ELITE LABS |
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AA | 040875 | KVK TECH |
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AA | 040886 | KVK TECH |
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AA | 205019 | NUVO PHARM |
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | Yes | AA | 086945 | SANDOZ |
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | Yes | AA | 087190 | SANDOZ |