4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2803]
Sandoz Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of
20 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants
notified the Agency in writing that the drug products were no longer marketed and requested that
the approval of the applications be withdrawn.
DATES: Approval is withdrawn as of [INSERT DATE 30 DAYS AFTER DATE OF
PUBLICATION IN THE FEDERAL REGISTER].
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993-0002, 301-796-3471, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The applicants listed in table 1 have informed FDA
that these drug products are no longer marketed and have requested that FDA withdraw approval
of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have
also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an
application or abbreviated application under § 314.150(c) is without prejudice to refiling.
Application No.
ANDA 040118

ANDA 040291

Table 1.--ANDAs for Which Approval Is Withdrawn
Drug
Applicant
Carisoprodol, Aspirin and Codeine
Phosphate Tablets, 325
milligrams (mg), 200 mg, and
16 mg
Fluorouracil Injection, 50
mg/milliliters (mL)

Sandoz Inc., 100 College Rd. West,
Princeton, NJ 08540

Fresenius Kabi USA, LLC, Three
Corporate Dr., Lake Zurich, IL
Application No.

Drug

ANDA 071849

Morphine Sulfate Injectable, 0.5
mg/mL

ANDA 074133

Metoprolol Tartrate Injectable, 1
mg/mL
Nitrofurantoin
(Monohydrate/Macrocrystals)
Capsules, 75 mg, and 25 mg
Ondansetron Hydrochloride (HCl)
Preservative Free Injection,
Equivalent to (EQ) 2 mg
base/mL
Ondansetron HCl Injectable, EQ 2
mg base/mL
Ondansetron HCl Injection, EQ 2
mg base/mL
Dexamethasone Sodium
Phosphate Injection, EQ 4 mg
phosphate/mL
Mepivacaine HCl and
Levonordefrin Injection, 0.05
mg/mL; 2%

ANDA 076648

ANDA 077387

ANDA 077582
ANDA 079039
ANDA 087440

ANDA 088388

ANDA 090578

ANDA 090579

ANDA 090723

ANDA 207266
ANDA 207794

Ampicillin and Sulbactam For
Injection, EQ 10 grams(g)
base/vial and EQ 5 grams (g)
base/vial
Ampicillin and Sulbactam For
Injection, EQ 1 g base/vial, EQ
500 mg base/vial, EQ 2 g
base/vial, and EQ 1 g base/vial
Duloxetine HCl Capsules,
Delayed-Release Pellets, EQ
20 mg base, EQ 30 mg base,
and EQ 60 mg base
Bupivacaine HCl Injectable,
0.75%
Busulfan Injection, 6 mg/mL

ANDA 209068

Chlorthalidone Tablets, 25 mg and
50 mg

ANDA 212223

Captopril Tablets, 12.5 mg, 25
mg, 50 mg, and 100 mg

Applicant
Hospira, Inc., 275 North Field Dr.,
Building H1-3S, Lake Forest, IL
60045
Do.
Aurobindo Pharma USA Inc., 279
Princeton-Hightstown Rd., East
Windsor, NJ 08520
American Regent, Inc., 5 Ramsey Rd.,
Shirley, NY 11967

Do.
Do.
Do.

ICON Clinical Research, LLC, U.S.
Agent for Deproco, Inc., 4130
ParkLake Ave., Suite 400, Raleigh,
NC 27612
EAS Consulting Group, LLC, U.S.
Agent for Astral SteriTech Pvt.
Ltd., 1700 Diagonal Rd., # 750,
Alexandria, VA 22314
Do.

Marksans Pharma, Inc., U.S. Agent
for Marksans Pharma Ltd., 150
Motor Pkwy., Suite 401, 4th Floor,
Rm. 430, Hauppauge, NY 11788
Baxter Healthcare Corp., One Baxter
Pkwy., Deerfield, IL 60015
Nexus Pharmaceuticals, Inc., 400
Knightsbridge Pkwy.,
Lincolnshire, IL 60069
Elity LLC, U.S. Agent for Sunny
Pharmtech Inc., 175 SW 166th
Ave., Pembroke Pines, FL 33027
Pharmobedient Consulting, LLC, U.S.
Agent for Seton Pharmaceuticals,
LLC, 642 North East 3rd Ave.,

Application No.
ANDA 212287

ANDA 212721

ANDA 213552

Drug
Piperacillin and Tazobactam For
Injection, EQ 2 g base/vial, EQ
250 mg base/vial, EQ 3 g
base/vial, EQ 375 mg base/vial,
EQ 4 g base/vial, and EQ 500
mg base/vial
Cefepime HCl For Injection, EQ 1
g base/vial and EQ 2 g
base/vial
Succinylcholine Chloride
Injection, 20 mg/mL

Applicant
Fort Lauderdale, FL 33304
EAS Consulting Group, LLC

Do.

Nexus Pharmaceuticals, Inc.

Therefore, approval of the applications listed in table 1, and all amendments and
supplements thereto, is hereby withdrawn as of [INSERT DATE 30 DAYS AFTER DATE OF
PUBLICATION IN THE FEDERAL REGISTER]. Approval of each entire application is
withdrawn, including any strengths and dosage forms inadvertently missing from table 1.
Introduction or delivery for introduction into interstate commerce of products listed in table 1
without an approved new drug application or ANDA violates sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are
listed in table 1 that are in inventory on [INSERT DATE 30 DAYS AFTER DATE OF
PUBLICATION IN THE FEDERAL REGISTER] may continue to be dispensed until the
inventories have been depleted or the drug products have reached their expiration dates or
otherwise become violative, whichever occurs first.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.

[FR Doc. 2024-13660 Filed: 6/20/2024 8:45 am; Publication Date: 6/21/2024]