Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210117
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | AB | No | No |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
10/12/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/05/2024 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
04/23/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
ALLOPURINOL
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 203154 | ACCORD HLTHCARE |
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077353 | CHARTWELL |
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 075798 | ENDO OPERATIONS |
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 214443 | HARMAN FINOCHEM |
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 217748 | HETERO LABS LTD V |
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 204467 | INDOCO |
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 090637 | IPCA LABS LTD |
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 018659 | MYLAN |
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 078253 | NORTHSTAR HLTHCARE |
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 071450 | SUN PHARM INDUSTRIES |
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 211820 | UNICHEM |
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 018832 | WATSON LABS |
ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 210117 | ZYDUS PHARMS |
LOPURIN | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 071586 | DR REDDYS LA |
ZYLOPRIM | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | Yes | AB | 016084 | CASPER PHARMA LLC |
TABLET;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 203154 | ACCORD HLTHCARE |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 077353 | CHARTWELL |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 075798 | ENDO OPERATIONS |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 214443 | HARMAN FINOCHEM |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 217748 | HETERO LABS LTD V |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 204467 | INDOCO |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 090637 | IPCA LABS LTD |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 018659 | MYLAN |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 078253 | NORTHSTAR HLTHCARE |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 071450 | SUN PHARM INDUSTRIES |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 211820 | UNICHEM |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 018877 | WATSON LABS |
ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 210117 | ZYDUS PHARMS |
LOPURIN | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 071587 | DR REDDYS LA |
ZYLOPRIM | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | Yes | AB | 016084 | CASPER PHARMA LLC |