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MORPHINE SULFATE

ANDA

MORPHINE SULFATE | A074769 | RHODES PHARMACEUTICALS LP

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: MS CONTIN(TE code: AB)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Aurolife Pharma LLC. FDA-2017-P-6307 Aurolife Pharma LLC submitted this citizen petition requesting that the FDA designate Morphine Sulfate Extended Release Tablets, 100 mg from Rhodes Pharmaceuticals LP (ANDA# A074769) as a reference standard for ANDA bioequivalence studies, because the original reference listed drug MS CONTIN (NDA# 0	505(q)	2017-10-30	Denied	Aurolife Pharma LLC.

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.

SPECGX LLCMORPHINE SULFATE

DMF 58571985

NORAMCO LLCMORPHINE SULFATE

DMF 69671987

VERANOVA LPMORPHINE SULFATE USP

DMF 215882008

PENICK CORPInactiveMORPHINE SULFATE

DMF 66801986

MACFARLAN SMITH LTDInactiveMORPHINE SULFATE

DMF 83281989

MALLINCKRODT INCInactiveMORPHINE SULFATE INJECTION USP

DMF 115291995

ELAN PHARMA LTDInactiveMORPHINE SULFATE

DMF 128081997

SIEGFRIED USA LLCInactiveMORPHINE SULFATE USP

DMF 196932006

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 2, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 2, 1998

No patent or exclusivity listings for this strength.

#002 — 200MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 2, 1998