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STILBESTROL

NDA

DIETHYLSTILBESTROL | N004056 | BRISTOL MYERS SQUIBB

15 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF19 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TIANJIN WEIJIE PHARMACEUTICAL CO LTDDIETHYLSTILBESTROL

DMF 309142016

IOWA STATE COLLEGEInactiveDIETHYLSTILBESTROL AS A CATTLE FEED ADDITIVE

DMF 1481940

COLORADO AGRICULTURAL & MECHANICAL COLLEGEInactiveDIETHYLSTILBESTROL IN CATTLE FEEDS --SAFETY OF USE OF

DMF 1891940

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveDIETHYLSTILBESTROL PWD & DIETHYLSTILBESTROL 50% SUSPEN. IN SOYBEAN OIL

DMF 2251940

WYETH-AYERST LABORATORIESInactiveDIETHYLSTILBESTROL IMPLANTATION PELLETS

DMF 3851960

CUDAHY PACKING COInactiveDIETHYLSTILBESTROL MIX IN-CUDAHY 3% PHOSPHORUS MIXER W/DES 0.0088%(VET

DMF 6691963

PACIFIC NORTHWEST PRODUCTS, INC.InactiveDIETHYLSTILBESTROL (VET)

DMF 6701963

INTERMOUNTAIN ELEVATOR CO.InactiveDIETHYLSTILBESTROL (VET)

DMF 6711963

IMPERIAL PRE-MIX CO.InactiveDIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

DMF 6721963

ALBION VETERINARY SUPPLYInactiveDIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

DMF 6731963

ARIZONA MILLING CO.InactiveDIETHYLSTILBESTROL INTERMEDIATE PREMIXES --BEEF CATTLE FEEDS (VET)

DMF 6831963

GEM FEED CO.InactiveDIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

DMF 6941963

CALIFORNIA CATTLE SUPPLY CO., INC.InactiveDIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

DMF 7111963

LAKE AND CRUICKSHANKInactiveDIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

DMF 7331963

PRO-VITA CO.InactiveDIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

DMF 7361963

MERCK CHEMICAL MANUFACTURING DIV MERCK CO INCInactiveDIETHYLSTILBESTROL TRADE NAME: RUMESTROL "1" AND "2" (VET)

DMF 7491955

MILBUR-ELLIS CO./TXInactiveDIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

DMF 7511963

SOUTHWEST FLOUR AND FEED CO.InactiveDIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

DMF 7691964

CONSUMERS COOPERATIVE ASSOCIATIONInactiveDIETHYLSTILBESTROL INTERMEDIATE PREMIXES -STILBOSOL (VET)

DMF 7701963

THE FARR COMPANYInactiveDIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

DMF 7751963

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

Products (15)

Sort:

#001 — 0.1MG

0 patents0 exclusivities▴

SUPPOSITORY;VAGINAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 0.5MG

0 patents0 exclusivities▾

SUPPOSITORY;VAGINAL | Approved: Approved Prior to Jan 1, 1982

#003 — 0.2MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — 0.5MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#005 — 1MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#006 — 5MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#007 — 0.1MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#008 — 0.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#009 — 1MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#010 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#011 — 0.1MG

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

#012 — 0.5MG

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

#013 — 1MG

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

#014 — 5MG

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

#017 — 0.25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982