Orange Book product

DICYCLOMINE HYDROCHLORIDE 10MG/ML

Orange Book ANDA 080614 · DR REDDYS LABORATORIES LTD · Discontinued

Key facts

Proprietary name DICYCLOMINE HYDROCHLORIDE
Active ingredients DICYCLOMINE HYDROCHLORIDE
Strength 10MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA080614
Applicant holder DR REDDYS LABORATORIES LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 11, 1986

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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