Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016401
Company: POLYMEDICA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOPAP ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter None 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
11/07/1968 ORIG-1 Approval Type 3 - New Dosage Form 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
10/16/1978 SUPPL-12 Labeling

Label is not available on this site.

10/18/1977 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

NEOPAP

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SUPPOSITORY;RECTAL; 120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACEPHEN ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter No 018060 ACP NIMBLE
ACETAMINOPHEN ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter No 070607 PERRIGO NEW YORK
ACETAMINOPHEN ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter Yes 018337 TARO PHARM INDS LTD
NEOPAP ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter No 016401 POLYMEDICA

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