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SUMATRIPTAN SUCCINATE

ANDA

SUMATRIPTAN SUCCINATE | A078284 | ORBION PHARMACEUTICALS PRIVATE LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: IMITREX(TE code: AB)

API Supply Chain15 active DMFs4 inactive

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

QUIMICA SINTETICA SASUMATRIPTAN SUCCINATE

DMF 153762001

DR REDDYS LABORATORIES LTDSUMATRIPTAN SUCCINATE

DMF 165342003

NATCO PHARMA LTDSUMATRIPTAN SUCCINATE

DMF 169302003

MOEHS IBERICA SLSUMATRIPTAN SUCCINATE

DMF 173522004

APITORIA PHARMA PRIVATE LTDSUMATRIPTAN SUCCINATE USP

DMF 193302006

ORBION PHARMACEUTICALS PRIVATE LTDSUMATRIPTAN SUCCINATE

DMF 193402006

SUN PHARMACEUTICAL INDUSTRIES LTDSUMATRIPTAN SUCCINATE USP

DMF 193722006

SMS PHARMACEUTICALS LTDSUMATRIPTAN SUCCINATE (ALTERNATIVE SYNTHESIS)

DMF 207462007

NATCO PHARMA LTDSUMATRIPTAN SUCCINATE (INJECTABLE GRADE)

DMF 208942007

MATRIX PHARMACORP PRIVATE LTDSUMATRIPTAN SUCCINATE USP

DMF 217112008

MSN PHARMACHEM PRIVATE LTDSUMATRIPTAN SUCCINATE USP [ROUTE CODE - "SU"]

DMF 224822009

DIVIS LABORATORIES LTDSUMATRIPTAN SUCCINATE AND SUMATRIPTAN

DMF 236242010

APITORIA PHARMA PRIVATE LTDSUMATRIPTAN SUCCINATE USP (PROCESS II)

DMF 322182017

CHROMO LABORATORIES INDIA PRIVATE LTDSUMATRIPTAN SUCCINATE USP

DMF 369722022

DR REDDYS LABORATORIES LTDSUMATRIPTAN SUCCINATE USP

DMF 375512022

SMS PHARMACEUTICALS LTDInactiveSUMATRIPTAN SUCCINATE

DMF 162792002

CIPLA LTDInactiveSUMATRIPTAN SUCCINATE USP

DMF 173972004

APOTEX PHARMACHEM INCInactiveSUMATRIPTAN SUCCINATE USP

DMF 230792009

ASYMCHEM LIFE SCIENCE TIANJIN CO LTDInactiveSUMATRIPTAN SUCCINATE

DMF 285902014

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 14, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 25MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 10, 2009

No patent or exclusivity listings for this strength.

#002 — EQ 50MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 10, 2009

#003 — EQ 100MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 10, 2009