Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018060
Company: G AND W LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACEPHEN ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter None No No
ACEPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter None No No
ACEPHEN ACETAMINOPHEN 325MG 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
02/09/1978 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
12/02/2014 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

03/25/2014 SUPPL-66 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018060Orig1s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018060Orig1s066ltr.pdf
11/01/2011 SUPPL-65 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018060s065ltr.pdf
04/01/2010 SUPPL-64 Labeling-Container/Carton Labels

Label is not available on this site.

04/28/2010 SUPPL-63 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018060s063ltr.pdf
02/15/2002 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

03/24/1999 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1996 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

03/31/1997 SUPPL-55 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-060S055.pdf
08/26/1987 SUPPL-53 Labeling

Label is not available on this site.

10/20/1987 SUPPL-52 Labeling

Label is not available on this site.

01/22/1985 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/1986 SUPPL-50 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/11/1983 SUPPL-49 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/22/1981 SUPPL-48 Labeling

Label is not available on this site.

12/18/1980 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

11/21/1980 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

11/25/1980 SUPPL-44 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/19/1980 SUPPL-43 Labeling

Label is not available on this site.

08/12/1980 SUPPL-42 Labeling

Label is not available on this site.

02/21/1980 SUPPL-39 Labeling

Label is not available on this site.

02/13/1980 SUPPL-38 Labeling

Label is not available on this site.

02/13/1980 SUPPL-37 Labeling

Label is not available on this site.

02/13/1980 SUPPL-36 Labeling

Label is not available on this site.

02/20/1980 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/11/1979 SUPPL-33 Labeling

Label is not available on this site.

11/06/1979 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/1979 SUPPL-31 Labeling

Label is not available on this site.

11/05/1979 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/22/1979 SUPPL-29 Labeling

Label is not available on this site.

09/12/1979 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/1979 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/24/1979 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/27/1979 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/14/1979 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/13/1979 SUPPL-21 Labeling

Label is not available on this site.

03/06/1980 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/17/1979 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/15/1979 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/05/1978 SUPPL-17 Labeling

Label is not available on this site.

08/31/1978 SUPPL-16 Labeling

Label is not available on this site.

10/06/1978 SUPPL-15 Labeling

Label is not available on this site.

10/06/1978 SUPPL-14 Labeling

Label is not available on this site.

10/06/1978 SUPPL-13 Labeling

Label is not available on this site.

10/06/1978 SUPPL-12 Labeling

Label is not available on this site.

10/05/1978 SUPPL-11 Labeling

Label is not available on this site.

10/05/1978 SUPPL-10 Labeling

Label is not available on this site.

10/05/1978 SUPPL-9 Labeling

Label is not available on this site.

10/05/1978 SUPPL-8 Labeling

Label is not available on this site.

10/06/1978 SUPPL-7 Labeling

Label is not available on this site.

10/05/1978 SUPPL-6 Labeling

Label is not available on this site.

10/06/1978 SUPPL-5 Labeling

Label is not available on this site.

10/05/1978 SUPPL-4 Labeling

Label is not available on this site.

10/06/1978 SUPPL-3 Labeling

Label is not available on this site.

10/06/1978 SUPPL-2 Labeling

Label is not available on this site.

05/03/1978 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/25/2014 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018060Orig1s066lbl.pdf

ACEPHEN

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

SUPPOSITORY;RECTAL; 650MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACEPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter No 018060 G AND W LABS
ACEPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter No 072237 G AND W LABS
ACETAMINOPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter No 070608 PERRIGO NEW YORK
ACETAMINOPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter Yes 018337 TARO PHARMS NORTH

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

SUPPOSITORY;RECTAL; 325MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACEPHEN ACETAMINOPHEN 325MG SUPPOSITORY;RECTAL Over-the-counter No 018060 G AND W LABS
ACEPHEN ACETAMINOPHEN 325MG SUPPOSITORY;RECTAL Over-the-counter No 072344 G AND W LABS
ACETAMINOPHEN ACETAMINOPHEN 325MG SUPPOSITORY;RECTAL Over-the-counter Yes 018337 TARO PHARMS NORTH

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 G AND W LABS
ACETAMINOPHEN ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter No 070607 PERRIGO NEW YORK
ACETAMINOPHEN ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter Yes 018337 TARO PHARMS NORTH
NEOPAP ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter No 016401 POLYMEDICA

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