Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087129
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription AA 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
07/09/1981 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
08/29/2002 SUPPL-19 Labeling

Label is not available on this site.

10/31/2000 SUPPL-18 Labeling

Label is not available on this site.

09/24/1997 SUPPL-17 Labeling

Label is not available on this site.

06/23/1997 SUPPL-16 Labeling

Label is not available on this site.

10/19/1993 SUPPL-15 Labeling

Label is not available on this site.

08/24/1993 SUPPL-14 Labeling

Label is not available on this site.

01/23/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/10/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/10/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English