Home NDC 70377-188 Deflazacort Oral Suspension
Product NDC 70377-188
11-digit product format 703770188
Labeler code 70377
Product ID 70377-188_3f0a59d0-17a9-264b-9081-b858e4198d98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Deflazacort Oral
Dosage form SUSPENSION
Route ORAL
Labeler Biocon Pharma Inc.
Application ANDA220709
Marketing category ANDA
Marketing start 2026-09-25
Substance DEFLAZACORT
Active strength 22.75 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220709-001 DEFLAZACORT DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2026-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220709-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A220709-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2026-05-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220709-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2026-05-28 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220709-001 DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB 2026-05-28 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A220709-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220709-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220709-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Deflazacort Oral Suspension
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFLAZACORT 22.75 mg/mL
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70377-188-21 70377018821 1 BOTTLE in 1 CARTON (70377-188-21) / 13 mL in 1 BOTTLE 1 bottle 2026-09-25 No No Current