Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 018659
Company: MYLAN
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 10/24/1986 | 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 |
|---|---|---|---|---|---|
| 03/12/2024 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2023 | SUPPL-30 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/23/2019 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2003 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/13/2002 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/16/1987 | SUPPL-1 | Manufacturing (CMC) |
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 | 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 | 075798 | VINTAGE PHARMS |
| 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 | 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 | 075798 | VINTAGE PHARMS |
| 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 |