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NATEGLINIDE

ANDA

NATEGLINIDE | A205248 | ZYDUS PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain8 active DMFs2 inactive

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

DR REDDYS LABORATORIES LTDNATEGLINIDE (PREMIX)

DMF 178472004

TAPI NL BVNATEGLINIDE

DMF 179102004

SYNTHIMED LABS PRIVATE LTDNATEGLINIDE USP

DMF 202312007

UNICHEM LABORATORIES LTDNATEGLINIDE

DMF 214842008

CADILA PHARMACEUTICALS LTDNATEGLINIDE FORM H USP

DMF 265182013

USV PRIVATE LTDNATEGLINIDE USP [MICRONISED]

DMF 268822013

UNICHEM LABORATORIES LTDNATEGLINIDE (FORM-H) USP

DMF 289342015

ZYDUS LIFESCIENCES LTDNATEGLINIDE USP

DMF 375012022

CIPLA LTDInactiveNATEGLINIDE USP

DMF 179062004

CADILA PHARMACEUTICALS LTDInactiveNATEGLINIDE FORM B

DMF 219622008

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 11, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 60MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 6, 2016

No patent or exclusivity listings for this strength.

#002 — 120MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 6, 2016