Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018877
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 09/28/1984 | 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 |
|---|---|---|---|---|---|
| 04/03/2024 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018832Orig1s056,s058,s061; 018877Orig1s063,s065,s068ltr.pdf | |
| 04/03/2024 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018832Orig1s056,s058,s061; 018877Orig1s063,s065,s068ltr.pdf | |
| 04/03/2024 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018832Orig1s056,s058,s061; 018877Orig1s063,s065,s068ltr.pdf | |
| 11/13/2015 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/2009 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 08/14/2002 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/2001 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/2003 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/30/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1993 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1988 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/03/2024 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf | |
| 04/03/2024 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf | |
| 04/03/2024 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf |
ALLOPURINOL
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 |