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OCTREOTIDE ACETATE

ANDA

OCTREOTIDE ACETATE | A204669 | HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SANDOSTATIN(TE code: AP)

API Supply Chain22 active DMFs4 inactive

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

POLYPEPTIDE LABORATORIES INCOCTREOTIDE ACETATE DRUG SUBSTANCE

DMF 149942000

SUN PHARMACEUTICAL INDUSTRIES LTDOCTREOTIDE ACETATE USP (PROCESS I)

DMF 176782004

TAPI NL BVOCTREOTIDE ACETATE

DMF 177772004

BCN PEPTIDES SAOCTREOTIDE ACETATE

DMF 187402005

CHEMI SPAOCTREOTIDE ACETATE

DMF 195672006

USV PRIVATE LTDOCTREOTIDE ACETATE USP

DMF 242882010

MATRIX PHARMACORP PRIVATE LTDOCTREOTIDE ACETATE USP

DMF 277292013

AMBIOPHARM INCOCTREOTIDE ACETATE

DMF 277592013

SUN PHARMACEUTICAL INDUSTRIES LTDOCTREOTIDE ACETATE USP (PROCESS-II)

DMF 279902014

AURO PEPTIDES LTDOCTREOTIDE ACETATE

DMF 294482015

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDOCTREOTIDE ACETATE

DMF 297102017

SCINOPHARM TAIWAN LTDOCTREOTIDE ACETATE

DMF 301312015

CHENGDU SHENGNUO BIOPHARM CO LTDOCTREOTIDE ACETATE USP

DMF 302492016

ALP PHARM BEIJING CO LTDOCTREOTIDE ACETATE

DMF 309922016

CHEMICAL AND BIOPHARMACEUTICAL LABORATORIES OF PATRAS SINGLE MEMBER SAOCTREOTIDE ACETATE

DMF 312772016

POLYPEPTIDE LABORATORIES SWEDEN ABOCTREOTIDE ACETATE

DMF 328632018

FRESENIUS KABI IPSUM SRLOCTREOTIDE ACETATE

DMF 341182020

BACHEM AGOCTREOTIDE ACETATE

DMF 341452019

HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDOCTREOTIDE ACETATE

DMF 358162021

PIRAMAL PHARMA LTDOCTREOTIDE ACETATE

DMF 363222021

ALEMBIC PHARMACEUTICALS LTDOCTREOTIDE ACETATE USP

DMF 379132022

HARBIN JIXIANGLONG BIOTECH CO LTDOCTREOTIDE ACETATE

DMF 399372024

BACHEM AMERICAS INCInactiveOCTREOTIDE ACETATE USP

DMF 167602003

POLYPEPTIDE LABORATORIES INCInactiveOCTREOTIDE ACETATE BY GRANULATION

DMF 217042008

WOCKHARDT LTDInactiveOCTREOTIDE ACETATE

DMF 220682008

HEMMO PHARMACEUTICALS PVT LTDInactiveOCTREOTIDE ACETATE

DMF 263302012

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

Products (3)

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#001 — EQ 0.05MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 27, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 0.1MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 27, 2018

#003 — EQ 0.5MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 27, 2018