Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018877
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
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.

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 APOTEX INC
ALLOPURINOL ALLOPURINOL 300MG TABLET;ORAL Prescription No AB 204467 INDOCO REMEDIES
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 078390 SUN PHARM INDS INC
ALLOPURINOL ALLOPURINOL 300MG TABLET;ORAL Prescription No AB 071450 SUN PHARM INDUSTRIES
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 USA INC
LOPURIN ALLOPURINOL 300MG TABLET;ORAL Prescription No AB 071587 DR REDDYS LA
ZYLOPRIM ALLOPURINOL 300MG TABLET;ORAL Prescription Yes AB 016084 CASPER PHARMA LLC

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