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TOLMETIN SODIUM

ANDA

TOLMETIN SODIUM | A073308 | ANI PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Quantum Pharmics, Ltd. FDA-1990-P-0044 Quantum Pharmics, Ltd. filed this citizen petition under section 505(j)(2)(c) of the Federal Food and Drug Act on January 9, 1990, requesting permission to file an Abbreviated New Drug Application for Tolmetin Sodium Tablets, USP, 400 mg, which differs from the listed drug Tolectin 600 (tolmetin sod	Other	2017-07-17	Granted	Quantum Pharmics

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

API Supply Chain1 active DMF11 inactive

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

MATRIX PHARMACORP PRIVATE LTDTOLMETIN SODIUM USP

DMF 220922008

ETHYL CORPInactiveTOLMETIN (MCN2559-21-98)

DMF 22941974

ETHYL CORPInactiveTOLMETIN (MCN 2559-21-98)

DMF 25141975

CILAG CHEMIE AGInactiveTOLMETIN SODIUM DIHYDRATE

DMF 25371975

MALLINCKRODT INCInactiveTOLMETIN SODIUM DIHYDRATE

DMF 27631976

MALLINCKRODT INCInactiveTOLMETIN SODIUM DIHYDRATE T.A.

DMF 27901976

ORGANICHEM CORPInactiveTOLMETIN SODIUM DIHYDRATE

DMF 41091981

NORAMCO INCInactiveTOLMETIN SODIUM DIHYDRATE

DMF 44411981

ORION CORP LTDInactiveTOLMETIN SODIUM

DMF 67831986

ALFA CHEMICALS ITALIANA SRLInactiveTOLMETIN SODIUM DIHYDRATE

DMF 72701987

COSMA SPAInactiveTOLMETIN SODIUM

DMF 73361988

AMSA SPAInactiveTOLMETIN SODIUM

DMF 164322003

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

Products (1)

#001 — EQ 400MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 24, 1992

No patent or exclusivity listings for this strength.