Viewing data from:

NIFEDIPINE

ANDA

NIFEDIPINE | A075289 | VALEANT PHARMACEUTICALS NORTH AMERICA LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: PROCARDIA XL(TE code: AB2)

API Supply Chain8 active DMFs30 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVNIFEDIPINE

DMF 61971985

FIS FABBRICA ITALIANA SINTETICI SPANIFEDIPINE USP

DMF 63391986

DIPHARMA FRANCIS SRLNIFEDIPINE USP

DMF 65051986

MOEHS IBERICA SLNIFEDIPINE

DMF 75041988

UNIQUE CHEMICALS (A DIV OF J B CHEMICALS AND PHARMACEUTICALS LTD)NIFEDIPINE USP

DMF 167302003

SHARON BIO MEDICINE LTDNIFEDIPINE USP

DMF 255572011

EIRCHEM PHARMA SERVICES LTDNIFEDIPINE

DMF 294972015

UNICHEM LABORATORIES LTDNIFEDIPINE USP

DMF 335622019

BAYER HEALTHCARE AGInactiveNIFEDIPINE

DMF 36721979

KRKA PHARMACEUTICAL AND CHEMICAL WORKSInactiveNIFEDIPINE

DMF 52951984

SUMIKA FINE CHEMICALS CO LTDInactiveNIFEDIPINE USP XX

DMF 55011984

CIPLA LTDInactiveNIFEDIPINE USP XXI

DMF 58811985

SIEGFRIED AGInactiveNIFEDIPINE

DMF 62461986

FARMOS GROUP LTD MEDIPOLARInactiveNIFEDIPINE

DMF 63031986

INTERMEDI CHIMICI SINTETICI SPA ZONA INDUSTRIALEInactiveNIFEDIPINE

DMF 63211986

LEK PHARMACEUTICAL AND CHEMICAL CO DDInactiveNIFEDIPINE

DMF 63351986

SELOC FRANCEInactiveNIFEDIPINE

DMF 67721987

ELAN PHARMA LTDInactiveNIFEDIPINE 50 MG. TABLETS

DMF 68291987

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANAInactiveNIFEDIPINE

DMF 68601987

DELMAR CHEMICALS INCInactiveNIFEDIPINE

DMF 72451987

IROPHARM LTDInactiveNIFEDIPINE

DMF 75631988

RP SCHERER NORTH AMERICA DIV RP SCHERER CORPInactiveNIFEDIPINE SOFTGELS 20 MG

DMF 77121988

RP SCHERER NORTH AMERICA DIV RP SCHERER CORPInactiveNIFEDIPINE SOFTGELS 10 MG

DMF 77131988

RP SCHERER NORTH AMERICA DIV RP SCHERER CORPInactiveNIFEDIPINE SOFTGELS 10 MG, TO SUPPORT CHELSEA LABS. ANDA

DMF 77411988

RP SCHERER NORTH AMERICA DIV RP SCHERER CORPInactiveNIFEDIPINE SOFTGELS 20 MG, TO SUPPORT CHELSEA LABS. ANDA

DMF 77421988

RP SCHERER NORTH AMERICA DIV RP SCHERER CORPInactiveNIFEDIPINE SOFTGELS 20 MG, KALIPHARMA, INC.

DMF 77521988

RP SCHERER NORTH AMERICA DIV RP SCHERER CORPInactiveNIFEDIPINE SOFTGELS 10 MG

DMF 77541988

CADILA LABORATORIES PVT LTDInactiveNIFEDIPINE

DMF 79341989

NORDIC SYNTHESIS ABInactiveNIFEDIPINE

DMF 80431989

EGIS PHARMACEUTICALS PRIVATE LTDInactiveNIFEDIPINE

DMF 87941990

PHARMACEUTICAL WORKS POLPHARMA SAInactiveNIFEDIPINE

DMF 91621991

BPRL FINE CHEMICALS PRIVATE LTDInactiveNIFEDIPINE BULK DRUG SUBSTANCE

DMF 92721991

SUMIKA FINE CHEMICALS CO LTDInactiveNIFEDIPINE

DMF 93171991

UNIQUE CHEMICALSInactiveNIFEDIPINE

DMF 102801993

EVONIK OPERATIONS GMBHInactiveNIFEDIPINE

DMF 119481996

CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTDInactiveNIFEDIPINE USP, (BULK ACTIVE PHARMACEUTICAL INGREDIENT), MANFACTURED IN TAIWAN, THE REPUBLIC OF CHINA

DMF 131151998

CATALENT PHARMA SOLUTIONS LLCInactiveNIFEDIPINE (10MG AND 20MG) SOFTGEL CAPSULE

DMF 152932001

BAYER AGInactiveNIFEDIPINE DRUG SUBSTANCE

DMF 295962015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 6, 2001	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 60MG

AB2

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 27, 2000

No patent or exclusivity listings for this strength.

#002 — 30MG

AB2

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 6, 2001