Application 203594

Type: ANDA
Sponsor: WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	TABLET;ORAL	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	No	No

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

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
A203594-001	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB		2016-10-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A203594-001	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
2026-08-01 22:54:32	2026-06	A203594-001	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB		2016-10-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A203594-001	AB	1	`a50c72e98297…`

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45689	ORIG	2016-10-27
45544	ORIG	2016-10-14