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METHYLTESTOSTERONE

ANDA

METHYLTESTOSTERONE | A204851 | IMPAX LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Novitium Pharma, LLC FDA-2020-P-1605 Novitium Pharma LLC filed this citizen petition under 21 C.F.R. § 10.30 on June 22, 2020, requesting that the FDA Commissioner designate Impax Laboratories Inc's methyltestosterone 10 mg oral capsule (ANDA A204851) as a reference standard because the previously listed reference standard TESTRED, app	505(q)	2020-06-23	Withdrawn	Novitium Pharma

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain3 active DMFs5 inactive

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

ASPEN OSS BVMETHYLTESTOSTERONE

DMF 38611980

FARMABIOS SPAMETHYLTESTOSTERONE (MICRONIZED)

DMF 255932011

NOVITIUM PHARMA LLCMETHYLTESTOSTERONE USP

DMF 343732019

KV PHARMACEUTICAL COInactiveMETHYLTESTOSTERONE

DMF 23101974

ROUSSELL UCLAFInactiveMETHYLTESTOSTERONE USP

DMF 37751980

SCHERING AGInactiveMETHYLTESTOSTERONE

DMF 47041982

SYNTEX USA INCInactiveMETHYLTESTOSTERONE

DMF 66791986

HENAN QUANXIN MEDICAL CHEMICAL TECHNOLOGY CO LTDInactiveMETHYLTESTOSTERONE USP

DMF 188042005

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

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Sep 21, 2015

No patent or exclusivity listings for this strength.