Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087056
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/10/1980 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
03/20/2009 SUPPL-45 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/087056s045lbl.pdf
07/29/2002 SUPPL-37 Manufacturing (CMC)-Facility

Label is not available on this site.

10/04/2002 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/12/2001 SUPPL-35 Manufacturing (CMC)-Facility

Label is not available on this site.

10/26/2000 SUPPL-34 Labeling

Label is not available on this site.

07/25/2000 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/2000 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

09/24/1999 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/20/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/24/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/24/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/17/1997 SUPPL-26 Labeling

Label is not available on this site.

03/10/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/13/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/27/1989 SUPPL-21 Labeling

Label is not available on this site.

11/12/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/12/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/06/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/08/1984 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/02/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/12/1982 SUPPL-12 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
03/20/2009 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/087056s045lbl.pdf

CYPROHEPTADINE HYDROCHLORIDE

TABLET;ORAL; 4MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AA 207783 APEX PHARMS INC
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AA 206676 BEXIMCO PHARMS USA
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AA 040644 BOSCOGEN
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AA 207555 ELYSIUM
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AA 087056 HERITAGE PHARMA
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AA 040537 MOUNTAIN
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AA 205087 NOVAST LABS
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AA 087129 PAR PHARM
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AA 209172 STRIDES PHARMA
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AA 206553 TWI PHARMS
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AA 208938 ZYDUS PHARMS

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