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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 018659
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
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 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 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
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