Application 213441

Type: ANDA
Sponsor: ZYDUS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	No	No
002	0	NORTRIPTYLINE HYDROCHLORIDE	CAPSULE;ORAL		No	No
003	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 50MG BASE	No	No
004	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A213441-001	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24
A213441-002	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24
A213441-003	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24
A213441-004	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24

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	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A213441-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2021-02-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A213441-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2021-02-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A213441-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2021-02-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A213441-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2021-02-24	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Zydus Lifesciences Limited	f22dce73-b895-4fe2-8cf7-816dca93c246	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213441 application number: ANDA213441 ndc (product): 70771-1612 ndc (product): 70771-1614 ndc (product): 70771-1615 ndc (product): 70771-1613
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	dbe85bdc-17a1-4201-bf48-a52e35d69b68	2024-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213441 application number: ANDA213441 ndc (product): 70710-1156 ndc (product): 70710-1153 ndc (product): 70710-1154 ndc (product): 70710-1155

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70710-1153	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1154	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1155	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1156	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1612	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1613	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1614	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1615	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	Cadila Healthcare Limited	ANDA	Current